Apparatus and methods for guiding a needle

ABSTRACT

A needle guiding apparatus includes a base, a guide assembly, and an imaging sight. The base defines an opening that extends through the base. The guide assembly includes at least one passage, and the guide assembly is disposed within the opening of the base. The guide assembly also is rotatable about at least one axis. The imaging sight is disposed adjacent the passage. An entry needle can be inserted through the needle guiding apparatus and into a body. Devices and methods according to the present invention allow a medical professional to accurately and rapidly place a probe, such as a needle, in a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit ofU.S. provisional patent application serial No. 60/131,058, filed Apr.26, 1999, and U.S. provisional patent application serial No. 60/136,291,filed May 27, 1999. The entire disclosure of each of these provisionalpatent applications is incorporated herein by reference.

TECHNICAL FIELD

[0002] The present invention relates to apparatus and methods forintroducing a needle into a body. More particularly, the inventionrelates to apparatus and methods for introducing a needle into a body ina particular orientation and in a stable manner.

BACKGROUND INFORMATION

[0003] Many medical procedures are undertaken through small tractsformed within a patient's tissue. These procedures are minimallyinvasive. In order to form the tract running from outside of the patientto a target within the patient, a probe typically is inserted in theinitial stages of a procedure. This probe will run from the surface ofthe patient's skin to the target. Later in the procedure, this initialinsertion can be enlarged to accommodate other medical devices necessaryfor the procedure.

[0004] Typically, inserting the probe is a time-consuming procedure. Theprobe must be positioned properly, typically under the guidance of anenergy emitting medical device, such as an x-ray emitting device. X-rayenergy passes through the patient's body and differentially impinges ona fluoroscope screen, exciting fluorescent material, such as calciumtungstate, to create a screen display of the body and probe. The probeis visualized on the fluoroscope as it enters the patient on the displayof the medical device. This probe can appear on the screen because itdoes not allow the energy to pass through it (i.e., it can be opaque).

SUMMARY OF THE INVENTION

[0005] The present invention allows for the positioning and insertion ofa probe, such as a needle, into a patient. A medical professionalmanipulates devices according to the invention such that a properlyaligned device will properly align an entry needle with a target in thepatient's body. Some of the advantages of these devices includeshortening the length of a procedure, allowing for a more precisepositioning of an entry needle which can, for example, reduce trauma totissue, and stabilizing the entry needle during placement. Specificembodiments can have these and other advantages described below.

[0006] In one aspect of the invention, a needle guiding apparatusincludes a base defining an opening extending therethrough; a guideassembly including at least one passage and being disposed within theopening; and an imaging sight disposed adjacent at least one passage.The guide assembly is rotatable about at least one axis

[0007] This aspect or any of the other aspects of the invention can haveany of the following features. The guide assembly can include a firsttransmission element between a first location within the opening and asecond location remote therefrom. The first transmission element can befor transferring angular movement between the second location and thefirst location, and the movement at the first location can occur about afirst one of the axes. The first transmission element can include afirst pulley proximate the first location and disposed coaxially withthe first axis of rotation and/or can further include a guide shaftdefining at least a portion of the at least one passage. Also, the firsttransmission element can include a belt for transferring angularmovement between the first location and the second location and/or caninclude a control shaft connected to a second pulley proximate thesecond location. The needle guiding apparatus also can include a lockfor preventing movement of the first transmission element.

[0008] The guide assembly can include a second transmission element fortransferring angular movement about a second one of the axes. The secondtransmission element can include an adjustment rod rotatable about thesecond axis extending through the adjustment rod. The imaging sight caninclude a radiopaque core of the adjustment rod. The imaging sight caninclude at least two parallel bars disposed within the adjustment rod.The needle guiding apparatus can include a lock for preventing movementof the adjustment rod. The first axis and the second axis can besubstantially perpendicular. The imaging sight can include a radiopaqueband disposed within the base. The guide assembly can include anadjustment rod. The adjustment rod can be rotatable about an axisextending through the adjustment rod and/or can be rotatable about anaxis extending through the passage.

[0009] The guide assembly can include a turret disposed within theopening. The turret can include an adjustment rod. The turret can berotatable about an axis extending through the opening, and/or theadjustment rod can be rotatable about an axis extending through theadjustment rod. The guide assembly can include a guide needle. The guideassembly can include a ball and socket joint disposed within the baseand can further include a guide shaft defining a portion of the passageand/or can further include a control arm connected to the guide assemblyand/or can further include a second ball and socket joint connected tothe control arm, thereby to replicate the movement of the second balland socket joint at the guide assembly. The second joint can be capableof locking into a position.

[0010] The imaging sight can be disposed coaxially about at least onepassage, and/or the imaging sight can include a ring, and/or the imagingsight can include at least one cross-hair. The imaging sight can includea material that is detectable with a fluoroscope, and the material thatis detectable with a fluoroscope can include a radiopaque material. Theguide assembly can include at least two of the passages, and thepassages can be disposed at known angles relative to the base. Theneedle guiding apparatus can include at least one clamp for attachingthe apparatus to a fixed surface. The guide assembly can be capable oflocking into a position. At least two of the axes about which the guideassembly rotates can be substantially perpendicular

[0011] The needle guiding apparatus can include an entry needle, theneedle capable of inserting through the passage. Any entry needle caninclude radiopaque cross-hairs to aid with aligning a needle guidingapparatus and/or the entry needle. The entry needle can include a firstassembly that includes a housing, a stylet extending into the housingand biased towards a distal end of the entry needle, and a hub adjacentthe housing at a proximal end of the entry needle and in connection withthe stylet, and the entry needle can include a second assembly thatincludes a cannula surrounding the stylet. The first assembly and thesecond assembly can seal together and can be separable. The hub can bemovable from a first position to a second position, the hub in the firstposition indicating that the entry needle is impeded by a tissue and thehub in the second position indicating that the entry needle is notsubstantially impeded by the tissue. The stylet can include a blunt edgeat its distal end, and/or the cannula can include an angled edge at itsdistal end, and/or the stylet can include an angled edge at its distalend, and/or the cannula can include a blunt edge at its distal end. Theentry needle can include a connector connected with the cannula forattaching a medical device to the entry needle.

[0012] The entry needle can include an inner needle coaxially surroundedby a cannula having an outer wall defining a lumen. The cannula can havean opening in the outer wall proximate a distal end of the entry needleand a branch proximate a proximal end of the entry needle, the innerneedle including a notch. The inner needle can be rotatable from a firstposition to a second position, the notched inner needle in the firstposition allowing communication between the opening and the branch andthe notched inner needle in the second position preventing communicationbetween the opening and the branch. The branch can be capable ofattaching to a suction device.

[0013] The entry needle can include an electromagnetic energy sensor.The entry needle can include a chemical sensor. The guide assembly canbe constructed such that it does not protrude past at least one side ofthe base.

[0014] In another aspect of the invention, a method for aiming a needleguiding apparatus includes the steps of providing a needle guidingapparatus that includes a base having an opening, a guide assemblydefining at least one passage and disposed within the opening, the guidebeing rotatable about at least one axis, and an imaging sight disposedadjacent the at least one passage; aligning the imaging sight with atleast a portion of a target, and with an energy source; and viewing thesight on a display. The providing step can include providing a needleguiding apparatus that includes an imaging sight that can be ring ofradiopaque material, a bar of radiopaque material, a cross-hair ofradiopaque material, cross-hairs of radiopaque material, perpendicularbars of radiopaque material, and/or a diamond shape of radiopaquematerial, and combinations thereof. The viewing step can include viewingthe imaging sight on the display, the imaging sight appearing tosurround at least the portion of the target and at least a portion ofthe guide assembly, thereby indicating proper alignment. The guideassembly can include a guide shaft, and the viewing step can includeviewing the imaging sight on the display, the imaging sight appearing tosurround the guide shaft and at least the portion of the target, therebyindicating proper alignment.

[0015] In another aspect of the invention, a needle guiding apparatusincludes a base defining an opening extending therethrough; a guideassembly including a turret rotatably mounted in the opening and anadjustment rod rotatably mounted in the turret, the guide assemblyincluding at least one passage therethrough; and an imaging sightdisposed adjacent at least one passage. The turret can include a groovefor interlocking with pins from the base, thereby to allow rotation ofthe turret within the base. Alternatively, the turret can be associatedwith the base using a friction fit, thereby to allow rotation of theturret within the base. The guide assembly can be constructed such thatit does not protrude beyond at least one side of the base.

[0016] In another aspect of the invention, a needle guiding apparatusincludes a base including a socket; a guide assembly including at leastone passage therethrough and including a ball articulable within thesocket and a guide shaft proximate the ball; and an imaging sightdisposed adjacent at least one passage. The needle guiding apparatusalso can include a connecting rod in operable connection with the guideassembly and with a mechanism, the mechanism being remote from the guideassembly, thereby to replicate movements of the mechanism at the guideassembly. The mechanism can include a base assembly that includes asocket, a ball being articulable in the socket, and a shaft proximatethe ball. The needle guiding apparatus also can include a lock, therebyto prevent movement of the guide assembly. The base can include anopening extending therethrough and the guide assembly can be disposedwithin the opening.

[0017] In another aspect of the invention, a needle guiding apparatusincludes a base, a dome, and a guide assembly that includes a stop anddefines a passage, such that the guide assembly is positionable atvarious locations through the dome and the guide assembly does notprotrude beyond at least one surface of the base. The dome can includean imaging sight.

[0018] In another aspect of the invention, a needle guiding apparatusincludes a base defining an opening extending therethrough; a guideassembly including a turret rotatable within the opening, the turretdefining at least two passages therethrough, the passages being at knownangles of entry relative to the base; and an imaging sight adjacent atleast one passage.

[0019] In another aspect of the invention, a needle guiding apparatusincludes a base defining an opening extending therethrough; a guideassembly including a guide needle including a passage therethrough, theguide needle being rotatable about an axis that extends through the baseand is substantially perpendicular to the guide needle; and an imagingsight adjacent the passage. The needle guiding apparatus also caninclude at least one driving bar for inserting an entry needle throughthe passage and/or can include at least one bar guide for sliding atleast one driving bar along a predetermined range of motion. The needleguiding apparatus also can include at least one driving bar for applyingforce to the guide assembly and/or include at least one bar guide, suchthat at least one driving bar is affixed to the at least one bar guideand that applied force is conveyed from the at least one driving bar tothe guide assembly.

[0020] In another aspect of the invention, a needle guiding apparatusincludes a base defining an opening extending therethrough; a guideassembly including an adjustment rod rotatable about an axis extendingthrough the adjustment rod and a guide needle extending through theadjustment rod and defining a passage extending therethrough; and animaging sight adjacent the passage. The needle guiding apparatus alsocan include a lock for preventing movement of the alignment rod. Theneedle guiding apparatus also can include at least one driving barassociated with an entry needle for applying force to the entry needle,the entry needle passing through the passage, and/or at least one barguide for sliding at least one driving bar along a predetermined rangeof motion. The needle guiding apparatus also can include at least onedriving bar for applying force to the guide assembly, and/or at leastone bar guide, such that at least one driving bar is affixed to the atleast one bar guide and that applied force is conveyed from the at leastone driving bar to the guide assembly.

[0021] In another aspect of the invention, an entry needle can include afirst assembly that includes a housing, a stylet extending into thehousing and biased towards a distal end of the entry needle, and a hubadjacent the housing at a proximal end of the entry needle and inconnection with the stylet. The entry needle also can include a secondassembly that includes a cannula surrounding the stylet. The firstassembly and the second assembly can seal together and can be separable.The hub can be movable from a first position to a second position, thehub in the first position indicating that the entry needle is impeded bya tissue and the hub in the second position indicating that the entryneedle is substantially unimpeded by the tissue. The stylet can includea blunt edge at its distal end, and/or the cannula can include an anglededge at its distal end, and/or the stylet can include an angled edge atits distal end, and/or the cannula can include a blunt edge at itsdistal end. The entry needle also can include a connector connected withthe cannula for attaching a medical device to the entry needle.

[0022] In another aspect of the invention, a needle guiding apparatusincludes a position holding device; a needle disposed within andcoaxially with the position holding device; a front aiming deviceproximate a distal end of the needle guiding apparatus and disposedcoaxially about the needle; and a rear aiming device proximate aproximal end of the needle driving apparatus and disposed coaxiallyabout the needle. The position holding device can include a needle. Atleast a portion of the position holding device can be radiopaque. Atleast a portion of the needle can be radiopaque. At least a portion ofthe front aiming device can be radiopaque. The front aiming device caninclude a circular portion. At least a portion of the rear aiming devicecan be radiopaque. The rear aiming device can include at least onecross-hair. The needle guiding apparatus also can include a trigger fordelivering the needle. The needle guiding apparatus also can include acannula having an outer wall defining a lumen and being coaxiallydisposed about the needle. The cannula can have an opening in the outerwall proximate the distal end and a branch proximate the proximal end,and the needle can include a notch. The needle can be rotatable from afirst position to a second position, the notched needle in the firstposition allowing communication between the opening and the branch andthe notched needle in the second position preventing communicationbetween the opening and the branch. The branch can be capable ofattaching to a suction device. A cannula can include an electromagneticenergy sensor. A cannula can include a chemical sensor.

[0023] In another aspect of the invention, a method of aiming a needleguiding apparatus includes the steps of providing a needle guidingapparatus that includes a position holding device, a needle disposedwithin and coaxially with the position holding device, a front aimingdevice proximate a distal end of the needle driving apparatus anddisposed coaxially about the needle, and a rear aiming device proximatea proximal end of the needle driving apparatus and disposed coaxiallyabout the needle; aligning a distal end of the needle with a target;aligning an energy source with an axis of the needle and the target; andaligning the distal end of the needle, the center of the front aimingdevice, and the center of the rear aiming device with the target.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention, and exemplary embodiments according to theinvention, are more particularly described in the following description,taken in conjunction with the accompanying drawings.

[0025] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating principles of the invention.

[0026]FIG. 1 depicts a schematic side view of a device with a turret andan adjustment rod, according to the invention.

[0027]FIG. 2 depicts a schematic exploded side view of the device ofFIG. 1.

[0028]FIG. 3 depicts a schematic enlarged side view of the device ofFIG. 1.

[0029]FIG. 4 depicts a schematic top view of the device of FIG. 1.

[0030]FIG. 5 depicts a schematic top view of the device of FIG. 1.

[0031]FIG. 6A depicts a schematic top view of the device of FIG. 1 inrelation to a patient's skin and a target.

[0032]FIG. 6B depicts a schematic display screen view of an unaligneddevice of FIG. 1.

[0033]FIG. 6C depicts a schematic display screen view of a partiallyunaligned device of FIG. 1.

[0034]FIG. 6D depicts a schematic display screen view of a properlyaligned device of FIG. 1.

[0035]FIG. 7 depicts a schematic top view of the device of FIG. 1 inrelation to a patients skin and a target, the device attached to a fixedsurface.

[0036]FIG. 8 depicts a schematic side view of a device including a balland socket joint and a movement duplicating mechanism, according to theinvention.

[0037]FIG. 9 depicts a schematic side view of the device of FIG. 8 inrelation to a patient's skin and a target.

[0038]FIG. 10 depicts a schematic top view of a domed device, accordingto the invention.

[0039]FIG. 11 depicts a schematic side view of the embodiment of FIG.10.

[0040]FIG. 12 depicts a schematic top view of a device with a turretcontaining passages at known angles relative to a base, according to theinvention.

[0041]FIG. 13 depicts a schematic side view of the embodiment of FIG.12.

[0042]FIG. 14 depicts a schematic side view of the dome of theembodiment of FIG. 12.

[0043]FIG. 15A depicts a schematic side view of a device with anadjustable guide needle, according to the invention.

[0044]FIG. 15B depicts a top view of an entry needle in the embodimentof FIG. 15A.

[0045]FIG. 16 depicts a schematic cross-section taken through line A-Aof the embodiment of FIG. 15A.

[0046]FIG. 17 depicts a schematic representation of a screen display ofthe embodiment of FIG. 15A while the device is in use.

[0047]FIG. 18A depicts a schematic side view of a device with anadjustment rod and a guide needle, according to the invention.

[0048]FIG. 18B depicts a schematic cross-section taken through line B-Bof the embodiment of FIG. 18A.

[0049]FIG. 19A depicts a schematic top view of the embodiment of FIG.18A;

[0050]FIG. 19B depicts a schematic partial side view of the embodimentof FIG. 19A.

[0051]FIG. 20 depicts a schematic top view of the embodiment of FIG. 18Arelative to a patient's skin and a target.

[0052]FIG. 21 depicts a schematic representation of a screen display ofthe embodiment of FIG. 18A while the device is in use.

[0053]FIG. 22 depicts a schematic side view of an entry needle in an“off” position.

[0054]FIG. 23 depicts a schematic side view of the embodiment of FIG. 22in an “on” position.

[0055]FIG. 24 depicts a schematic side view of an entry needle thatsenses electromagnetic radiation.

[0056]FIG. 25 depicts a schematic side view of an entry needle that hasa chemical reaction sensor.

[0057]FIG. 26 depicts a schematic side view of a device for driving anentry needle.

[0058]FIG. 27 depicts a schematic view through a cross-section of asight along line A-A of the embodiment of FIG. 26.

[0059]FIG. 28 depicts a schematic perspective view of a device having atrigger for driving an entry needle.

[0060]FIG. 29 depicts a schematic perspective view of the device of FIG.28 with an entry needle of FIG. 22.

[0061]FIG. 30A depicts a schematic perspective view of the device ofFIG. 28 with an entry needle of FIG. 24.

[0062]FIG. 30B depicts a schematic view of a device to provideelectromagnetic radiation to the device of FIG. 30A.

[0063]FIG. 31 depicts a schematic side view of one embodiment of aneedle guide apparatus and an embodiment of an entry needle in use.

[0064]FIG. 32 depicts a schematic top view of the needle guide apparatusof FIG. 31.

[0065]FIG. 33 depicts a schematic side view of the needle guideapparatus of FIG. 31 without the entry needle.

[0066]FIG. 34 depicts a schematic side view of the embodiment of FIG. 31in use.

[0067]FIG. 35 depicts a schematic end view of the embodiment of FIG. 31in use.

[0068]FIG. 36 depicts a highly schematic top view of the device of FIG.31 in relation to a patient and a medical professional, and a schematicimage display seen by the medical professional while positioning thedevice and/or components of the device in relation to a first axis.

[0069]FIG. 37A depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is symmetric about a first axis.

[0070]FIG. 37B depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is not symmetric about a first axis.

[0071]FIG. 37C depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is symmetric about a first and secondaxis.

[0072]FIG. 37D depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is not symmetric about a first axis.

[0073]FIG. 38 depicts a highly schematic top view of the device of FIG.31 in relation to a patient and a medical professional, and a schematicimage display seen by the medical professional while positioning thedevice and/or components of the device in relation to a second axis.

[0074]FIG. 39A depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is not symmetric about a second axis.

[0075]FIG. 39B depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is symmetric about a first and secondaxis.

[0076]FIG. 39C depicts a schematic view of a display in which a guideshaft of the embodiment of FIG. 31 is not symmetric about a second axis.

[0077]FIG. 40A depicts a schematic end view of a slightly alteredembodiment of the device of FIG. 31 with a guide shaft that is notaligned with a target.

[0078]FIG. 40B depicts a schematic image display with the device of FIG.40A in the position indicated in FIG. 40A.

[0079]FIG. 41A depicts a schematic end view of a slightly alteredembodiment of the device of FIG. 31 with a guide shaft that is alignedwith a target.

[0080]FIG. 41B depicts a schematic image display with the device of FIG.41A in the position indicated in FIG. 41A.

[0081]FIG. 42A depicts a schematic sectional view of one embodiment ofan entry needle with a blunt-edged stylet and an angled-edge cannula.

[0082]FIG. 42B depicts a schematic sectional view of the embodiment ofFIG. 42A with the stylet pushed proximally.

[0083]FIG. 42C depicts a schematic sectional view of the embodiment ofFIG. 42A as the stylet is removed from the cannula.

[0084]FIG. 43A depicts a schematic sectional view of one embodiment ofan entry needle with an angled-edge stylet and an blunt-edge cannula.

[0085]FIG. 43B depicts a schematic sectional view of the embodiment ofFIG. 43A with the stylet pushed proximally.

[0086]FIG. 43C depicts a schematic sectional view of the embodiment ofFIG. 43A as the stylet is removed from the cannula.

[0087]FIG. 44A depicts a schematic sectional view of the embodiment ofFIG. 42A as the entry needle enters a kidney.

[0088]FIG. 44B depicts a schematic sectional view of the embodiment ofFIG. 42A as the entry needle enters a target calyx.

[0089]FIG. 44C depicts a schematic sectional view of the embodiment ofFIG. 42A as the stylet is removed from the cannula.

[0090]FIG. 44D depicts a schematic sectional view of the embodiment ofFIG. 42A after the stylet is removed and the cannula with connector isleft behind.

[0091]FIG. 45 depicts a close-up a schematic sectional view, similar tothat shown in FIG. 44A, of the embodiment of FIG. 42A as the entryneedle enters a kidney.

[0092]FIG. 46 depicts a schematic top view an embodiment similar to thatof FIG. 31 having a slightly different control for guiding an entryneedle.

[0093]FIG. 47 depicts a schematic side view of the embodiment of FIG.46.

[0094]FIG. 48A depicts a schematic side view of a portion of a slightlyaltered embodiment of the device of FIG. 31 for use with an MRI deviceor a CAT-scan device.

[0095]FIG. 48B depicts a schematic end view of a slightly alteredembodiment of the device of FIG. 31 that is not aligned with a targetand that is for use with an MRI device or a CAT-scan device.

[0096]FIG. 48C depicts a schematic image display with the device of FIG.48A in the position indicated in FIG. 48B.

[0097]FIG. 49A depicts a schematic side view of a portion of a slightlyaltered embodiment of the device of FIG. 31 for use with an MRI deviceor a CAT-scan device.

[0098]FIG. 49B depicts a schematic end view of a slightly alteredembodiment of the device of FIG. 31 that is aligned with a target andthat is for use with an MRI device or a CAT-scan device.

[0099]FIG. 49C depicts a schematic image display with the device of FIG.49A in the position indicated in FIG. 49B.

[0100]FIG. 50 depicts a schematic image display of the device in FIG.49A in the position indicated in FIG. 49B and with the image of a guideshaft shown.

[0101]FIG. 51A depicts a schematic top view of a slightly alteredembodiment of the device of FIG. 31 for use with a magnetic resonanceimaging device (“MRI device”) or a computerized axial tomographyscanning device (“CAT-scan device”).

[0102]FIG. 51B depicts a schematic side view of the embodiment of FIG.51A.

[0103]FIG. 51C depicts a schematic section view taken at a point wherean alignment bar reaches an edge of a ring of the embodiment of FIG.51A.

[0104]FIG. 51D depicts a schematic section view taken at a point wherean alignment bar reaches an edge of a ring (on the opposite side of thering from FIG. 51C) of the embodiment of FIG. 51A.

[0105]FIG. 51E depicts the embodiment of FIG. 51A that is aligned with atarget.

[0106]FIG. 51F depicts a schematic image display of the embodiment ofFIG. 51A in the position shown in FIG. 51E.

DESCRIPTION

[0107] Devices and methods according to the present invention allow amedical professional to accurately and rapidly place a probe, such as aneedle, in a patient. Some of these devices allow a medical professionalto adjust the trajectory of an entry needle such that a target withinthe body is quickly located and the needle is rapidly inserted through apatient's tissue to the target area. For example, devices of the presentinvention allow medical professionals to gain easier, faster antegradeaccess during a percutaneous nephrolithotomy (“PCNL”) procedure. Whileplacement of the entry needle is described herein mainly as relating toa PCNL procedure, devices and methods according to the invention areuseful in many medical procedures involving placement of a probe. Forexample, insertion of an entry needle into a patient's spinal column isjust one example of other medical procedures that are applicable to thepresent invention.

[0108] Several techniques are currently used to perform PCNL procedures.Antegrade access to a kidney involves a medical professional inserting aneedle through a patient's back and into his kidney. Typically, amedical professional will guide an entry needle to a target calyx withinthe kidney under the guidance of a fluoroscope or a similar device.Briefly, a fluoroscope is a device that is used with an x-ray emittingdevice in order to visualize body structures and/or medical instruments.The x-ray energy is either transmitted through material that istransparent to the energy or is modulated by radiopaque material. Afterthe x-ray energy is either transmitted or modulated, the fluoroscopedetects at least some of the energy. Radiopaque material appears as animage on a display of the fluoroscope, while other transparent materialsthat are not radiopaque do not appear on the display. For example,medical devices can be constructed of radiopaque and/or transparentmaterial, depending upon whether or not they are to be visualized duringa procedure. Additionally, radiopaque contrast dyes can be injected intoa body structure or tissue, such as a target calyx in a kidney, so thatthe structure or tissue can be visualized on the screen of thefluoroscope display. The term “radiopaque” generally refers to asubstance that at least partially prevents transmission (by blocking,reflecting, absorbing, defracting, and/or any similar phenomenon) of atleast one type of electromagnetic radiation, such that an image of thesubstance will appear on a display. In the embodiments described herein,the most typical use of radiopaque materials is in conjunction with anx-ray emitting device and/or a fluoroscope. However, other energyemitting devices and/or visualization devices similar to a fluoroscopeare suitable for use with apparatus and methods according to theinvention. Additionally, although the embodiments described hereinusually refer to radiopaque materials for use as an imaging sight, theembodiments can include imaging sights that can be used with devicesother than an x-ray emitting device and/or a fluoroscope (such as an MRIdevice or a CAT-scan device). If the materials used for the imagingsight are changed from, for example, a metal to, for example, afluid-filled or a gas-filled material with a known density, then suchmaterials can be seen with the MRI device or CAT-scan device but may notbe able to be seen with a fluoroscope.

[0109] One type of PCNL procedure typically is performed using atriangulation technique which utilizes a needle that is 18 to 21 gauge,an x-ray emitting device; and a fluoroscope. The medical professionalfirst aligns the tip of the needle (on the patient's back) with thetarget calyx (visualized by injecting a radiopaque dye into the kidney)in a vertical position with the x-ray emitting portion of the x-raydevice (“x-ray head”) and the fluoroscope also in the vertical position,defining the needle's point of entry. (“Vertical” typically means anaxis extending perpendicular from the point of entry. When the needle isin a vertical position, it can be aligned along this axis with the x-rayhead and the fluoroscope at certain points of the procedure). Themedical professional will then re-position the x-ray head and thefluoroscope to a 30 degree angle from the vertical position whilekeeping the needle in the vertical orientation (or at a slight anglefrom the vertical position). By using the x-ray head and the fluoroscopein the vertical and 30 degree positions and viewing the needle on adisplay associated with the fluoroscope, the medical professional willapproximate the desired needle entry angle and trajectory to reach thetarget calyx as well as the needle's depth in the patient's tissue. Themedical professional then pushes the needle through the entry point,towards the target calyx. As necessary, the medical professional movesthe x-ray head and the fluoroscope between the two views and the needletrajectory can be adjusted to successfully achieve access into the headof the target calyx. Typically, multiple rounds of trajectory adjustmentare necessary in order to achieve access, and this process is often timeconsuming. The medical professional uses tactile feedback and the twoviews to determine when the target calyx has been successfully reachedby the tip of the needle. The final check to confirm access into thekidney is performed by the physician removing the needle (the needletypically is disposed within a trocar having a hub), attaching a syringeto the hub, and aspirating. If urine is aspirated, kidney access hasbeen achieved. If access has not been achieved, the entry needle must berepositioned and syringe reattached for further aspiration. Onedifficulty with this procedure is performing three dimensional accessusing two dimensional views.

[0110] A second technique for performing a PCNL procedure is known asthe “bullseye” technique. A patient is typically oriented on his/herside at an angle to an operating table such that a target calyx isgenerally aligned with the operating table (for example, the calyx isperpendicular to the table). A medical professional attempting kidneyaccess with this technique will typically first align the tip of a guideneedle on the patient's back with the target calyx (visualized byinjecting a radiopaque dye into the kidney) using the x-ray head and thefluoroscope in vertical position, defining the needle's point of entry.The medical professional will then insert the guide needle, for examplea 13 gauge needle, vertically through this entry point and about 2-3 cminto the patient's fatty tissue layers. This needle acts as the guidefor an entry needle. A physician typically will clamp a pair of forcepsaround the 13 gauge needle and hold the forceps at their proximal end,allowing the physician to adjust the orientation of the 13 gauge needlewhile keeping his/her hands out of the fluoro field (i.e., the field ofenergy given off by the x-ray emitting device). When the medicalprofessional has aligned the radiopaque hub of the 13 gauge needle withthe target calyx, and with the x-ray head and the fluoroscope invertical orientation, an 18 gauge entry needle is inserted through the13 gauge needle, into and through the patient's tissue, and into thepatient's kidney. A properly aligned guide needle, which can have aradiopaque outer wall, will appear in the screen display of thefluoroscope as a circle that circumscribes at least a portion of atarget calyx with an entry needle, which also can be radiopaque, in thecenter of the circle. The medical professional typically uses tactilefeedback to determine if access into the kidney is achieved. The medicalprofessional typically confirms that access into the kidney is achievedby removing an inner portion of the entry needle, attaching a syringe,and aspirating for urine through the space left by the removed portionof the entry needle. The presence of urine confirms access into thekidney. Many variations on this technique are possible. This techniquealso may require multiple attempts at positioning the entry needle andconnecting and disconnecting a syringe for access confirmation, and thistechnique, too, is a time consuming process.

[0111] The present invention saves procedure time and improves targetingaccuracy by giving the medical professional a tool to better control andalign the movement of the entry needle through the back and into thetarget calyx of the kidney. In certain embodiments, a medicalprofessional can use devices according to the invention while keepinghis or her hands away from the energy given off by an x-ray (or otherenergy) emitting device, and/or the medical professional can maintainthe ability to have tactile feedback during insertion of the entryneedle. Additionally, in certain embodiments, the medical professionalcan lock the needle guiding apparatus (or components thereof) intoalignment with the target calyx, and/or can stabilize the apparatus byattachment to a fixed object (such as an operating table). A medicalprofessional also can have the ability to remove his/her hands fromcertain embodiments according to the invention without movement of theentry needle trajectory. Also, the entry needle to be inserted throughcertain embodiments of the invention can travel through about 60 degreesof rotation in all planes from vertical (and more than about 60 degreesor less than about 60 degrees in certain embodiments) and/or can beinserted completely into target calyx. Devices according to theinvention can accommodate, for example, but without limitation, 18 to 21gauge entry needles, and can have the ability for the handle design toprevent interference with the surface of the skin (e.g., wingedhandles).

[0112] Referring to FIGS. 1-7, one needle guiding apparatus 2 accordingto the invention includes a base 4, a turret 6, and an adjustment rod 8.At one end of the base 4, a ring 24 is formed from the base 4 orattached to the base 4. At the other end of the base 4, a handle 14 isapplied to or formed from the base 4. The turret 6 has a groove 22 alongone edge and is mounted inside of and rides within the ring 24. Pins 16protrude through the ring 24 at holes 20 through the ring 24 and intothe groove 22. These pins 16 secure the turret 6 within the base 4.Alternatively, the turret 6 can fit within the ring 24 with a frictionfit.

[0113] The adjustment rod 8 is inserted through the turret 6 such thatthe adjustment rod 8 contacts the turret 6 and is held within the turret6, but is still free to rotate. For example, a groove can be cut intothe surface of and around the entirety of the adjustment rod 8. In thisinstance, the adjustment rod 8 is held in place by one or more pinsinserted through one or both of the top and the bottom of the turret 6(similar to how the turret 6 is held in the ring 24). Alternatively, theadjustment rod 8 can be held within the turret 6 with a friction fit.Atop the adjustment rod 8, a dome 10 having a radiopaque sight 34 isaffixed to or is a unitary member of the adjustment rod 8. The sight 34can be formed from the dome 10 if it is itself radiopaque, eitherpartially or totally, or the dome can have radiopaque markings appliedto it. For example, the radiopaque sight 34 on the dome 10 can becircular (such as a “donut” or a ring) to facilitate location of atarget calyx 902 in a manner similar to the bullseye technique.Alternatively or in addition, the sight can be a diamond shape, in theshape of a cross-hair, in the shape of a perpendicular cross-hair, orany combination, such that device alignment is facilitated. A guideshaft 12 extends through the dome 10 and the adjustment rod 8. When theneedle guiding apparatus 2 is properly aligned, described more fullybelow, this guide shaft 12 is aligned with the target calyx 902 andallows a medical professional to insert an entry needle 18 through theguide shaft 12 that provides a straight path into a patient as describedmore fully below. The guide shaft 12 can be relatively longer than theone shown and/or can include an extension. Typically, transparentcomponents of the needle guiding apparatus 2 are manufactured from aplastic through an injection-molding process. However, the adjustmentrod 8 can be radiopaque and, in that case, can be constructed from ametal such as stainless steel. Also, the sight, if radiopaque, is madefrom a radiopaque material such as a metal or a metalized coating.

[0114] The turret 6 rotates 360 degrees about its axis, best shown inFIGS. 4 and 5. For example, in FIG. 4, the turret 6 is shown rotated 180degrees from the handle 14, as indicated by arrow A. In addition torotating in a counter-clockwise direction, as shown by arrows A and D inboth FIGS. 4 and 5, the turret 6 can rotate in a clockwise direction asshown by arrow E between an outline of the adjustment rod 8 a and thebase 4. Additionally, the adjustment arm 8 itself rotates about its ownaxis, as shown by arrows B and C. The adjustment arm 8 can rotate inboth a clockwise and a counter-clockwise direction about its own axis(arrows B and C). In this embodiment, a medical professional can use twohands. One hand steadies the device 2 at the handle 14, for example,while the other hand adjusts the alignment rod 8 along directions oftravel A, B, C, D and/or E.

[0115] In operation, the apparatus 2 typically lies in the plane 30 of apatient's skin, shown in highly schematic fashion in FIGS. 6A and 7. Aplane drawn through the ring 24 is parallel to the plane of the skin 30.Additionally, the base 4 typically either touches a patient's skin or isjust adjacent to the skin. No needle is necessary to hold the deviceonto a patient's skin (although one could be used in this embodiment orany embodiment). The device 2 is operable with a single hand, especiallywhen moving the adjustment rod 8 short distances from being aligned withthe base 4 and handle 14. The medical professional typically presses thedevice 2 onto the top surface of the patient's skin while holding thehandle 14 and controls the alignment rod 8 with his thumb. Pushing thetip of a rotation knob 78 will rotate the alignment rod 8 in thedirection of arrow G. Pushing near the base of the rotation knob 78 willrotate the alignment rod 8 about the center of the ring 24 (arrow F).For larger movements, the alignment rod 8 can be adjusted with themedical professional's other hand.

[0116] In one method, the medical professional identifies the entry siteand a needle plane 32 on the patient's back by laying the bottom of thebase 4 flat (or nearly flat) against the skin layer and aligning theradiopaque sight 34 on the dome 10 with the target calyx 902 using anx-ray emitting device and a fluoroscope. The needle plane 32 in thiscase is along the long axis of the target calyx 902. Typically, amedical professional chooses this axis for easy visual reference on thefluoroscope screen, but any axis through a calyx can be chosen to definethe needle plane. Rotation (arrow F) of the turret 2 and alignment rod 8about the center of the ring 24 aligns the needle plane 32 through whichthe entry needle 18 passes. Rotation (arrow G) of the alignment rod 8about its own axis, controls the trajectory of the guide shaft 12 andthe entry needle 18, which is inserted through the guide shaft 12 andinto a patient. This trajectory occurs within the needle plane 32.Briefly, the medical professional checks the intended entry trajectoryor plane alignment and adjusts the apparatus 2 by matching the angle ofthe x-ray head and the fluoroscope to the angle of the optionallyradiopaque guide shaft 12, the radiopaque sight 34 on the dome 10, andthe target calyx 902. Once correct alignment is confirmed on thefluoroscope display screen, the medical professional can lock thealignment rod 8 into position. For example, a screw can lock thealignment rod 8 into place. The entry needle 18 is positioned into theguide shaft 12 and advanced towards the target calyx 902. The medicalprofessional can use the fluoroscope to confirm the advancement of entryneedle 18 into the target calyx 902.

[0117] When properly aligned, the apparatus 2 is adjusted to a positionsuch that the entry needle follows a particular trajectory a in theplane 32, leading to the target calyx 902 of the kidney 900.One-improperly aligned setting of the apparatus 2 is shown with theentry-needle trajectory along a trajectory βin the same plane 32 as theproper trajectory α. The improper trajectory β, while in the same planeas the proper trajectory α, is not aligned with the target calyx 902.This improper alignment can be corrected by rotating the adjustment rod8 clockwise (direction of travel G) to achieve the proper trajectory α.

[0118] These properly and improperly aligned states are shown as screendisplays on, for example, a screen display 800 of a fluoroscope, inFIGS. 6B and 6C, respectively. In FIG. 6B, the image 34 i of the imagingsight 34 appears atop the target calyx 902 in the screen display 800 ofthe fluoroscope. The image 12 i of the guide shaft 12 is not inalignment with the needle plane 32. The guide shaft is moved indirection F as the turret 2 is moved in direction F. Rotation indirection F brings the image 12 i of the guide shaft 12 into alignmentwith the needle plane 32 (FIG. 2C). Although the guide shaft 12 is inthe needle plane 32 at this point, the guide shaft 12 is aligned alongthe improper trajectory β. In fact, in one of many incorrectorientations, the guide shaft 12 is not aligned with the center of thesight 34, such that the image 12 i of the guide shaft 12 appears outsidethe image 34 i of the sight 34, unaligned with the center of the targetcalyx 902. Additionally, the image 34 i of the sight 34 appearsnon-circular (e.g., elliptical) because the sight 34 is not completelyperpendicular to the proper trajectory axis α, and, hence, the guideshaft 12 (about which the sight 34 is disposed) also appearsnon-circular and is not aligned with the target calyx 902. When thisimproperly aligned image appears, the device 2 is further aligned bymoving the adjustment rod 8 in direction G until the screen displayimage looks like the one shown in FIG. 6D. In FIG. 6D, the entry needle18 (located at least partially within the guide shaft 12) along aproperly aligned trajectory a appears as a needle tip 36 in the screendisplay 800. If shown in an enlarged-image, the needle tip 36 can appearcircular. This tip 36 is surrounded by a circular image 12 i of theguide shaft 12 and a circular image 34 i of the sight 34 above thetarget calyx 902. The image 34 i of the sight 34 and the image 12 i ofthe guide shaft 12 appears circular with the tip 36 in their center whenthe x-ray head and the fluoroscope are held along the same axis a as theentry needle 18 (and guide shaft 12) and when the sight 34 of the dome10 is in a plane that is perpendicular to the axis a. Hence, the guideshaft 12 (about which the sight 34 is disposed and through with theentry needle is inserted) is aligned with the target calyx 902. Thiseasy adjustment of an improperly aligned device can save procedure timeand can increase accuracy in targeting the target calyx.

[0119] Now referring to FIG. 7, a second example of proper δ andimproper ε device alignment is shown. However, these trajectories δ, εare attained with the adjustment rod 8 in a different position than inFIG. 6A. The plane 33 in which the needle trajectories δ, ε fall in FIG.7 is rotated from the plane 32 in which the needle trajectories α, βfall by the same amount that the adjustment rod 8 is rotated from itsposition in FIG. 6A to its position in FIG. 7. Adjustment of the needletrajectories δ, ε and the needle plane 33 is accomplished by moving theadjustment rod 8 along directions of movement I and J, as described fordirections of movement F and G, respectively, in FIG. 6A above. A screendisplay while adjusting an improperly aligned device to a properlyaligned device changes and appears similar to those shown in FIGS. 6B,6C and 6D.

[0120] Additionally, the apparatus 2 is attached to a stand 26 withvarious adjustments possible γ₁, γ₂, γ₃, γ₄, γ₅, and γ₆. The stand 26 isattached to a fixed surface 28, such as an operating table. Thisattachment may be advantageous for stabilizing the device 2 because, insome instances, the surface of the skin can move. Also, the medicalprofessional can remove his hands from the device 2 without disturbing adesired needle trajectory. The stand 26 could be secured such that thedevice 2 rests on the surface of the skin or slightly above.

[0121] Now referring to FIG. 8, another embodiment of a needle guidingapparatus 48 is depicted. The apparatus 48 has a base 50. The base 50has one opening at either end. One opening contains a guide component 52and the other opening contains a base component 54. Each of the guidecomponent 52 and the base component 54 have a groove (60, 74respectively) that holds each assembly in the base in the mannerdescribed for the turret of the apparatus in FIGS. 1-7. Alternatively,each component 52, 54 can be held in the base 50 by a friction fit, canbe bonded to the base 50, and/or can be the same piece of material asthe base 50.

[0122] The guide component 52 contains a socket 58. A ball 56 fitswithin the socket 58, and a guide shaft 64 extends from the ball 56. Aradiopaque sight 62 surrounds the guide shaft 64 on top of the ball 56.The guide shaft 64 has a passageway extending through it and inalignment with a passageway through the ball. The entry needle 18 can beinserted through these passageways. With the guide shaft 64 in place,the ball 56 articulates in the socket 58 in all directions, the range ofmotion limited only by the guide shaft 64 coming into contact with theupper edge of the guide component 52 and/or the socket 58. A control arm66 is connected with the guide shaft 64 at a joint. At the other end ofthe control arm 66, an extension 68 is connected to the control arm 66at a second joint. The extension 68 is attached to a ball 70 thatarticulates in a socket 72 and is contained within the base component 54in a similar fashion to the ball 56 and socket 58 located within theguide component 52. When a medical professional moves, for example, theextension 68, the movement is replicated at the guide shaft 63 whichultimately also duplicates the rotational angle of the extension 68. Themedical professional adjusts the plane in which the entry needle 18travels and the trajectory along which the entry needle 18 travels witha single movement of the extension 68 (i.e., control is not separatedinto two process as described above in the embodiment of FIGS. 1-7). Alock 80 can be used to prevent the ball 70 and extension 68 from movingin order to lock the guide shaft 64 into its intended trajectory. Thelock 80 can be, for example, a screw.

[0123] Now referring to FIG. 9, the apparatus 48 is placed on, or inclose proximity to, a patient's skin, represented by a plane 76. Thus,the apparatus 48 lies flat (or nearly flat) against the patient's skin.The apparatus 48 can include a handle 82 or be attached to a stand, asdescribed above. A medical professional manipulates the extension 68 (orsimilar structures such as a “joy stick”) and the movement istranslated, through the control arm 66, to the guide shaft 64 and ball56. Positioning the passage through the guide shaft 64 and ball 56properly allows the entry needle 18 to be properly positioned within apatient. When properly positioned, the apparatus 48 guides an entryneedle 18 along a proper trajectory a to reach the target calyx 902. Ifnot properly positioned, the apparatus 48 will guide an entry needle 18along in improper trajectory τ, and the entry needle 18 will not reachthe targeted area. The apparatus 48 has a sight 62 located coaxiallywith and disposed about the guide shaft 64. The medical professionaladjusts the needle guiding apparatus using a fluoroscope display screenin a manner similar to that described for FIGS. 6B, 6C, and 6D above,where the proper trajectories α, σ shown in FIGS. 6A and 9 correspondwith each other and the improper trajectories β, τ shown in FIGS. 6A and9 correspond with each other. This embodiment also can increase theaccuracy with which the entry needle is placed and can decreaseprocedure time by allowing more rapid placement and access to the targetcalyx.

[0124] In another embodiment of the invention, and referring to FIGS. 10and 11, a dome 102 is disposed within or attached to a base 100. Aradiopaque sight 104 is applied to or is integral with the dome 102. Inoperation, a medical professional inserts a guide needle 106 into thedome 102 under the guidance of a fluoroscope. The guide needle 106 ishollow and includes a guide needle stop 108 that, in conjunction withthe dome's 102 shape, prevents the guide needle 106 from penetrating apatient's skin surface prior to alignment of the device. The medicalprofessional checks the intended entry trajectory and/or alignment ofthe guide shaft 106 for the entry needle by approximately matching theangle of the x-ray head and the fluoroscope to the angle of theoptionally radiopaque guide needle 106, radiopaque sight 104 and thetarget calyx and viewing the fluoroscope display, as described above. Anentry needle can be inserted through the properly aligned guide needle106.

[0125] In another embodiment, and referring to FIGS. 12, 13, and 14, aneedle guiding apparatus 132 includes a turret 122 that rotates within aring 130 of a base 120. The turret 122 includes guide shafts 124, 126,128 (not all guide shafts are labeled). Radiopaque material can alignwith the walls defining the guide shafts 124, 126, 128 such that thematerial forms a ring, and/or at least a portion of the walls of theguide shafts 124, 126, 128 can be constructed from a radiopaquematerial. A medical professional can rotate the turret 122 by graspingthe protrusion containing guide shafts 124, 126, 128 and twisting theturret 122 (arrow K) in either a clockwise or counter-clockwisedirection. Each guide shaft 124, 126, 128 extends through the turret 122and is disposed at a different angle relative to the base 120. Forexample, two guide shafts 124, 126 that are adjacent to each other havedifferent angles relative to the base (φ, χ, respectively, as shown inFIG. 14). Thus, rotating the turret 122 can change the plane in which anentry needle will travel, but the needle trajectory is determined by theangle of the particular guide shaft. In use, the medical professionalsubstantially matches the angle of the x-ray head and the fluoroscopewith the angle of the guide shaft being used, such that a screen displayshows the calyx circumscribed within a circular image of the radiopaquematerial when the device is properly aligned.

[0126] Now referring to FIGS. 31-33, another embodiment of theinvention, shows a needle guiding apparatus 256 capable of directions ofmovement P and R. A handle 258 is connected with an adjustment rod 264through a connector 288. Within the adjustment rod 264, a pulley 272,optionally with a gear, is connected to an axial 268 extending throughthe pulley 272 so that the pulley 272 can rotate about the axial 268. Acontrol shaft 290 runs through the handle 258 and axial 268, and acontrol nut 292 is threaded onto the control shaft 290 so that thecontrol nut 292 can be tightened against the handle 258 to hold thecontrol shaft 290 in a particular position. A base 262 runs along thebottom of the device 256 and at one end, opposite the handle 258, opensinto a ring 286. The ring 286 can have bars of radiopaque material 282a, 282 b, 296 a, 296 b disposed on or within it. The sections ofradiopaque material can be situated such that the material 282 a, 282 b,296 a, 296 b forms cross-hairs (for example, they are perpendicular) andcan be aligned in the same horizontal plane as an axis extending throughthe center of the adjustment rod 264. Alternatively, radiopaque materialcan be located in the core of the adjustment rod 264. For ease ofdescription, the sections (or bars) of radiopaque material 282 a, 282 bthat are aligned with the axis of the adjustment rod 264 will bereferred to as a first band of radiopaque material, and the sections (orbars) of radiopaque material 296 a, 296 b that are perpendicular to thefirst band will be referred to as a second band of radiopaque material.A radiopaque marker shape 275 is located on the ring 286 and aids amedical professional in orienting the needle guiding apparatus 256 withthe patient's body under fluoroscopic guidance by providing a point ofreference.

[0127] Inside the ring 286, a second pulley 274, optionally connectedwith a gear, is connected to a second axial 270 that extends through thepulley 274 so that the pulley 274 can rotate about the axial 270. Thesecond axial 270 rotates about the axis formed by the second band ofradiopaque material 296 a, 296 b and about the axis formed by the axisextending through the adjustment rod 264 and the first band ofradiopaque material 282 a, 282 b. An optionally radiopaque guide shaft284 runs through the second axial 270, and the guide shaft 284 defines apassage extending through it. The guide shaft 284 is perpendicular tothe axis through the second axial 270 (the axis that is aligned with thesecond band of radiopaque material 296 a, 296 b). An entry needle 254can be inserted through the guide shaft 284, out the opening in the base262 created by the ring 286, into a patient's skin 260, and into atarget calyx 902 in the patient's kidney 900. A belt 266 located withinthe alignment rod 264 connects the first pulley 272 and the secondpulley 274. This belt 266 transfers angular movement about the axials268, 270 such that movement at one axial is transferred to the otheraxial. This movement is indicated as direction of movement P. Thecontrol shaft 290 can be used to move the axials 268, 270, pulleys 272,274, and belt 266 so that the guide shaft 284 moves. The movement of thecontrol shaft 290 can be replicated at the guide shaft 284 in a 1:1ratio, or the movement can be transferred such that a small movement atthe control shaft 290 produces a large movement at the guide shaft 284,or the movement can be transferred such that a large movement at thecontrol shaft 290 produces a small movement at the guide shaft 284. Thecontrol nut 292 can be fastened when the medical professional hasselected a desired position of the guide shaft 284 along direction ofmovement P. Other components can be used to transfer angular momentumfrom a control shaft to a guide shaft. For example, a pulley can includea groove or teeth so that the belt can ride in the groove or thatgrooves or teeth on the belt can enmesh with the teeth on the pulley.Alternatively, a series of gears can be used to transfer movement alongthe device, without a belt Also, gears can be used with the belt andpulley system so that greater than or less than a 1:1 ratio of movementat the control shaft and guide shaft is produced, allowing for finegradations of movement at the guide shaft. Also, linkage arms can beused to connect and transfer movement between the control shaft and theguide shaft.

[0128] The device 256 includes components that are moveable about anaxis that is perpendicular to the axis about which movement P isgenerated. The handle 258 is connected to the adjustment rod 264 throughthe connector 288 such that as the handle 258 is moves, it moves in anarc that has its center aligned with the axis of the adjustment rod 264.Thus, moving the handle 258, in turn, rotates the adjustment rod 264.Moving the handle 258 and adjustment rod 264 moves the guide shaft indirection R and, also, moves the control shaft in direction R. Thetransmission elements, including the axials 268, 270, pulleys 272, 274,and belt 266, are housed within the adjustment rod 264 and rotate withthe adjustment rod 264 along its axis. This direction of movement R isperpendicular to direction of movement P. A lock 276 has a screw 278that tightens onto the adjustment rod 264 that fits within a groove 280,to prevent the adjustment rod 264 from moving and, thus, prevent theguide shaft 284 from moving.

[0129] Directions of movement P and R typically are indicated as anarrow with two heads in the drawings, because, typically movement canoccur in a “positive” or “negative” direction. For example, direction ofmovement P can have a positive and negative direction. Thus, in relationto direction of movement P, positive movement is in the oppositedirection from negative movement but occurs along the same line or samearc of rotation (direction P) as the negative movement. However, in someinstances, as described throughout the specification, while “positive”or “negative” movement in a given direction (such as +P, −P or +R, −R)is indicated in the Figures and is possible, movement in only thepositive or negative direction may be appropriate. This explanationapplies to the other directions of movement described in the otherembodiments according to the invention (for example, A, B, C, D, E, F,G, H, I, J, K, L, Q, S, and T can have positive or negative directionsof movement). The terms “positive” and “negative” are arbitrary and aremeant merely to convey the concept of opposite directions of movement.

[0130] In a variation on this embodiment, an embodiment shown in FIGS.46 and 47 is a device 298 has essentially the same components as theembodiment of FIGS. 31-33 and moves in both the P and R directions in asimilar manner. However, the device 298 that has the direction ofmovement R controlled in a slightly different manner. Rather than thehandle 258 rotating with the adjustment rod 264, the control shaft 290,housed in a control shaft housing 300, also can be moved in direction Rto control the rotation of the adjustment rod 264 in direction R,transferring movement in the R direction to the guide shaft 284. Eitherone or both of the control shaft 290 and control shaft housing 300 canmove in direction R. The same movement of the adjustment rod 264 indirection R is generated as would be generated with the handle 258 inthe embodiment shown in FIGS. 31-33. This movement of the control shaft290 in both the R and P directions simultaneously moves the guide shaft284 in the same directions (R and P). Only one control lever is neededto control movement of the guide shaft 284 in both directions (R and P).Movement of the guide shaft 284 in the P direction in this alternativeembodiment is controlled similarly to the embodiment in FIGS. 31-33. Theembodiments shown in FIGS. 31-33 and 4647 can either have a sharp object(not shown) that inserts into a patient's skin to facilitate holding thedevice along the patient's skin or it can lack such a sharp object withthe device held in place by the medical professional and/or anattachment that stabilizes the device in association with a object thatis fixed in position, such as an operating table.

[0131] Now referring to FIGS. 34-41B, operation of the needle guideapparatus 256 of FIGS. 31-33 is described stepwise as a medicalprofessional might perform a procedure on a patient 1000 with the device256. FIGS. 34-41B are oriented such that the patient 1000 is laying onthe patient's right side, facing the medical professional, so that thepatient's 1000 left kidney 900 is positioned above the patient's rightkidney (not shown). The patient would face away from the physician, withthe right kidney positioned over the left kidney, if the right kidney isto be accessed. Also, in some instances, a kidney is accessed with thepatient laying on his/her stomach. This procedure is described for aright-handed medical professional such that the medical professionalholds the apparatus 256 in his/her left hand and inserts an entry needle(not shown) through the guide shaft 284 with his/her right hand. One caneasily discern a procedure for a left-handed medical professional whowould hold the apparatus in the right hand and the entry needle in theleft hand.

[0132] In FIG. 34, a needle guiding apparatus 256 is situated above apatient's 1000 left side, with the patient 1000 facing the medicalprofessional. The entire apparatus 256 is not shown, as designated by ablank area 302. A source of energy, such as an x-ray head 904 of anx-ray emitting device, projects energy. The x-ray head 904 is shown intwo different positions 904 a and 904 b. The medical professionalidentifies an entry site based on a patient's anatomy (e.g., the regionnear the twelfth rib is one appropriate entry site) and positions theapparatus 256. The apparatus 256 is horizontal and parallel to thelength of an operating table 906 in the x-axis direction and eithertouches or is close to the patient 1000. The medical professional 1001first determines the intended needle trajectory through a first plane304 by rotating the x-ray head 904 in a first position 904 a (directionS) in a y-z plane. A view from the perspective of the patient's feet ofthe same situation is shown in FIG. 35. The two positions 904 a, 904 bof the x-ray head 904 are along the first plane 304 and appear tooverlap although the x-ray head 904 in a second position 904 b is behindthe x-ray head 904 in a first position 904 a in this view. As shown inFIG. 36, the radiopaque bars of the first band 282 a, 282 b form images282 ai, 282 bi on a display screen when the fluoroscope is in operation.The orientation of the needle guiding device 256 (shown in a highlyschematic fashion) is shown relative to the screen display. As the x-rayhead 904 positioned in the first position 904 a is rotated in directionS, images 282 ai, 282 bi of the radiopaque bars 282 a, 282 b of thefirst band move in the fluoroscope display (shown as multiple bar images282 ai, 282 bi). The rotation of the x-ray head 904 (direction S) iscontinued until at least one of the images 282 ai, 282 bi of the bars282 a, 282 b of the first band is aligned with the target calyx 902,shown, for example, as the darkened image bars 282 ai, 282 bi. Images296 ai, 296 bi of the bars 296 a, 296 b of the second band are in anarbitrary position. When the images 282 ai, 282 bi of the bars 282 a,282 b of the first band are aligned, the x-ray head 904 is locked inplace and cannot rotate in direction S. This procedure defines the firstplane 304.

[0133] Next the angle of the guide shaft 284 is adjusted so that it isin the first plane 304. The angle of the guide shaft 284 is adjusted inthe first plane 304 (direction R) by turning the handle 258 (directionR). A mark (not shown) on the end of the adjustment rod 264 can alignwith angle markings (not shown) provided on the lock 276 such that themark moves as the handle 258 is turned (direction R) and aligns with theangle markings on the lock 276. When the angle indicated by thealignment of the mark and the angle marking matches the angle of thex-ray head 904, the guide shaft 284 is considered aligned with the firstplane 304 (for example, as in FIG. 35, the guide shaft 284 might bemoved in direction R to come into alignment with first plane 304). Atthat point, the medical professional tightens the screw 278 to lock theguide shaft 284 in position in the first plane 304.

[0134] The angle of the guide shaft 284 also can be aligned in the firstplane 304 by using the image of the guide shaft 284 i and the radiopaquebars 282 ai, 282 bi, as shown in FIGS. 37A-37D. FIGS. 37B and 37D showan image 284 i of the guide shaft 284 that is not symmetrical about theaxis of the image 282 ai, 282 bi of the first band. This type of imageindicates that the guide shaft 284 is not in the first plane 304. Inorder to align the guide shaft 284, it is rotated in direction R, forexample, with the handle 258. The rotation of the guide shaft 284 (Le.,rotation of the handle 258) is stopped when the image 284 i of the guideshaft 284 is symmetrical about the axis formed by the image 282 ai, 282bi of the first band, as shown in FIGS. 37A and 37C. In FIG. 37A theimage 284 i of the guide shaft 284 is symmetrical about the axis formedby the image 282 ai, 282 bi of the first band, while the image 284 i ofthe guide shaft 284 is symmetrical about both the axis formed by theimage 282 ai, 282 bi of the first band, and the axis formed by the image296 ai, 296 bi of the second band in FIG. 37C. Once the image 284 i ofthe guide shaft 284 is aligned along the axis formed by the image 282ai, 282 bi of the first band, the screw 278 is tightened to lock theguide shaft 284 in position in the first plane 304. The result in FIG.37C (proper alignment in both the first plane 304 and a second plane306) may occur in some instances without additional alignment steps,but, if less than proper alignment in both planes 304, 306 occurs, suchas shown in FIG. 37A, then further alignment steps may be used.

[0135] Once the guide shaft 284 is aligned along the axis formed by theimage 282 ai, 282 bi of the first band, the second plane 306 can bedetermined. With the x-ray head 904 of the fluoroscope locked in thefirst plane 304, the x-ray head 904 is rotated in the first plane 304(for example, from the first x-ray head position 904 a to the secondx-ray head position 904 b, i.e., direction T, as shown in FIG. 34). Thedirection of movement T in the first plane 304 generally is along thelength of the patient 1000, from the head to toe, and vice versa. Asshown in FIG. 38 in relation to a highly schematic depiction of theneedle guiding device 256, patient 1000, and medical professional 1001,the radiopaque bars of the second band 296 a, 296 b form images 296 ai,296 bi on a display screen when the fluoroscope is in operation. As thex-ray head 904 is rotated in direction T, images 296 ai, 296 bi of theradiopaque bars 296 a, 296 b of the second band move in the fluoroscopedisplay (shown as multiple bar images 296 ai, 296 bi). The rotation ofthe x-ray head 904 (direction 1) is continued until at least one of theimages 296 ai, 296 bi of the bars 296 a, 296 b of the second band isaligned with the target calyx 902, shown, for example, as the darkenedimage bars 296 ai, 296 bi. When the images 296 ai, 296 bi of the bars296 a, 296 b of the second band are aligned, the x-ray head 904 islocked in place and cannot rotate in direction T. This procedure definesthe second plane 306. At this point, the first plane 304 and the secondplane 306 are perpendicular.

[0136] Next the angle of the guide shaft 284 is adjusted so that it isin the second plane 306. The angle of the guide shaft 284 is adjusted bymoving the control shaft 290 (direction P) in the first plane 304. Anglemarkings (not shown) can be provided on the handle 258 and/or theconnector 288 and/or the control shaft housing 300 such that as thecontrol shaft 290 is moved (direction P) it aligns with the anglemarkings, indicating the angle of the control shaft 290 (and the guideshaft 284). When the indicated angle matches the angle of the x-ray head904, then the guide shaft 284 is aligned with the second plane 306. Atthat point, the medical professional tightens the control nut 292 tolock the guide shaft 284 in position in the second plane 306 while theguide shaft 284 is already locked in position in the first plane 304.

[0137] The angle of the guide shaft 284 also can be aligned in thesecond plane 306 by using the image of the guide shaft 284 i and theradiopaque bars 296 ai, 296 bi, as shown in FIGS. 39A-39C. In each ofFIGS. 39A-C, the image 284 i of the guide shaft 284 is alreadysymmetrical about the first plane 304 due to previous alignment steps,discussed above. FIGS. 39A and 39C show an image 284 i of the guideshaft 284 that is not symmetrical about the axis formed by the image 296ai, 296 bi of the second band. This image situation indicates that theguide shaft 284 is not properly aligned in the second plane 306. Inorder to align the guide shaft 284, it is rotated in the first plane 304(direction P), for example, with the control shaft 290. The rotation ofthe guide shaft 284 (i.e., movement of the control shaft 290) is stoppedwhen the image 284 i of the guide shaft 284 is symmetrical about theaxis formed by the image 296 ai, 296 bi of the second band, as shown inFIG. 39B. In FIG. 39B the image 284 i of the guide shaft 284 is nowsymmetrical about both the axis formed by the image 282 ai, 282 bi ofthe first band and the axis formed by the image 296 ai, 296 bi of thesecond band. Once the image 284 i of the guide shaft 284 is alignedalong the axis of the image 296 ai, 296 bi of the second band, thecontrol nut 292 is tightened to lock the guide shaft 284 in position inthe second plane 306. A proper entry needle trajectory to the targetcalyx is determined. At this point an entry needle, such as the one 254shown in FIG. 31, can be inserted into the guide shaft 284 and throughthe patient's 1000 tissue to the target calyx 902. If the angle markermethod of guide shaft 284 alignment is used, proper alignment (i.e.,attainment of proper entry needle trajectory) can be confirmed byviewing the positioned device 256 on the display screen. A properlyaligned device should appear as shown in FIG. 39B. If it is not aligned,the process can be repeated. This embodiment also can increase theaccuracy with which the entry needle is placed and can decreaseprocedure time by allowing more rapid and accurate placement and accessto the target calyx. A medical professional's hands are kept out of thex-ray field and tactile feedback as the entry needle is advanced intothe patient and the target calyx is maintained.

[0138] An alternative method of aligning the guide shaft 284 in thefirst plane 304 that uses a slightly altered version of the needleguiding apparatus 256 of FIGS. 31-33 is shown in FIGS. 40A-41B. In thisembodiment, the needle guiding apparatus can be horizontal to theoperating table but need not be horizontal. In this situation, inaddition to the first band of radiopaque material 282 a, 282 b in thedevice, two more bars 308 a, 310 a of radiopaque material are located,for example, in the alignment rod 264. These extra bars 308 a, 310 a ofradiopaque material are situated such that they are parallel to thefirst band of radiopaque material 282 a, 282 b. In FIG. 40A, the x-rayhead 904 is aligned along the first plane 304 with the target calyx 902.However, the guide shaft 284 is not properly aligned with the targetcalyx 902. As a result, the images 282 ai, 308 ai, 310 ai of the threeradiopaque bars 282 a, 308 a, 310 a, shown in FIG. 40B, appear as threeseparate images. The adjustment rod 264 is rotated in direction R, forexample with handle 258, and brought into proper alignment with thefirst plane 304, as shown in FIG. 41A. As a result, the images 282 ai,308 ai, 310 ai of the three radiopaque bars 282 a, 308 a, 310 a, shownin FIG. 41B, are superimposed and appear as a single image. In certainother embodiments, the devices of the invention can have two parallelradiopaque bars (rather than three) or can have more than three parallelradiopaque bars. Again, alignment of the guide shaft 284 is indicatedwhen the images of the bars are superimposed.

[0139] Two other alternative methods of aligning the guide shaft 284 inan image plane 305 that use slightly altered versions of the needleguiding apparatus 256 of FIGS. 31-33 are shown in FIGS. 48A-50 and FIGS.51A-51F. These two embodiments are designed for use with an MRI deviceor a CAT-scan device, rather than for use with an x-ray emitting deviceand a fluoroscope. When using such devices, the device can beimmediately aligned with the target calyx in a single image plane 305(i.e., the procedure can be performed without the step of perpendicularaligning bars contained within the base, as was done with bars 282 a,282 b, 296 a, 296 b above, to define the first plane 304 and the secondplane 306). Embodiments for use with an MRI device or a CAT-scan devicedo not use radiopaque materials, such as metals, for an imaging sightbecause metal produces a distorted screen display image. Theseembodiments instead would use a material with a particular density, suchas a fluid-filled or gas-filled structure. Additionally, because theenergy field produced by an MRI device or a CAT-scan device is not asharmful to human tissue as the energy field produced by an x-rayemitting device, embodiments of needle guiding apparatus for use with anMRI device or a CAT-scan device can be constructed such that they do nothave handle extensions or remote needle guiding capability. For example,medical professional could directly manipulate a guide shaft. However,for the sake of simplicity, the two alternative embodiments shown inFIGS. 48A-50 and FIGS. 51A-51F are presented as essentially the same asthat shown in FIGS. 31-33 except for the placement of and materialcomposition of the imaging sight. Also, rather than the medicalprofessional placing the device in the orientation shown in FIGS.34-39C, the device is rotated 90 degrees from that orientation. Althoughthe device still moves in directions P and R, the directions of movementP and R have been relabeled as Q and H, respectively, because directionsof movement P and R are rotated 90 degrees relative to those shown inFIGS. 34-39C due to the 90 degree rotation of the device. Thus,directions of movement Q and H are rotated 90 degrees from directions ofmovement P and R, but the device still produces rotational movement asdescribed above. These embodiments also can increase the accuracy withwhich the entry needle is placed and can decrease procedure time byallowing more rapid placement and access to the target calyx.

[0140] Now referring to FIGS. 48A-50, a needle guiding apparatus hasthree sets of parallel density bars 336 a, 336 b, 338 a, 338 b, 340 a,340 b. One set of density bars 336 a, 336 b forms a first density band,a second set of density bars 338 a, 338 b forms a second density band,and a third set of density bars 340 a, 340 b forms a third density band.These density bands are disposed within the adjustment rod 264 and arelocated symmetrically about the guide shaft 284. In FIG. 48B, the MRIdevice or CAT-scan energy source 910 is aligned along the image plane305. The second density band is also in the image plane 305. The needleguiding apparatus is situated above the patient's 1000 left side withthe patient 1000 facing the medical professional. The needle guidingapparatus is horizontal as well as perpendicular to the length of theoperating table 906 in the z-axis direction. The guide shaft 284 is notaligned within the image plane 305. Thus, as shown in FIG. 48C, an image(taken as a section through the image plane 305) shows only the images338 ai, 338 bi of the density bars 338 a, 338 b of the second densityband because only that density band is in line with the section taken bythe MRI device or the CAT-scan device. However, as shown in FIGS.49A-49C, the guide shaft 284 can be rotated (direction of movement H) tobring it into alignment with the image plane 305. Now, an image taken asa section will show all density bands because they are all aligned alongthe section line (i.e., the image plane 305). When the guide shaft 284is aligned as shown in FIG. 49B, the image of the density bands changessuch that the images 336 ai, 336 bi of the density bars 336 a, 336 b ofthe first density band are parallel with the images 338 ai, 338 bi ofthe density bars 338 a, 338 b of the second density band and areparallel with the images 340 ai, 340 bi of the density bars 340 a, 340 bof the third density band. This change in alignment can occur, forexample, as shown in FIG. 50 where an image 284 i of the guide shaft 284is shown in relation to the images 336 ai, 336 bi, 338 ai, 338 bi, 340ai, 340 bi of the density bars 336 a, 336 b, 338 a, 338 b, 340 a, 340 bof the three density bands and the target calyx 902. Also, in FIG. 50,the image 284 i of the guide shaft 284 can be moved in direction Q froma position similar to that shown in FIG. 49B (dotted outline of theimage of a guide shaft in FIG. 50) to a position aligned with the targetcalyx 902 similar to that shown in FIG. 50. Once the guide shaft 284 isfully aligned by moving the guide shaft 284 in both the H and Qdirections of movement, an entry needle can be inserted through theguide shaft 284.

[0141] Another layout of density bars 350 a, 350 b, 352 a, 352 b, 354 a,354 b for the embodiment shown in FIGS. 51A-51F is useful for bringingthe center of the guide shaft 284 into alignment with the image plane305. As shown in FIGS. 51A-51D, the embodiment has the same layout ofcomponents as the embodiment shown in FIGS. 31-33, except the densitybands 350 a, 350 b, 352 a, 352 b, 354 a, 354 b, that are viewed on theMRI device or CAT-scan device, are different in orientation andcomposition from the radiopaque bands shown in FIGS. 31-33. A firstdensity band is made up from the top two density bars 350 a, 350 b, asecond density band is made up from the middle two density bars 352 a,352 b, and a third density band is made up from the bottom two densitybars 354 a, 354 b. As seen in the various views, the density bars 352 a,352 b of the second density band are parallel with the first and thirddensity bands, but are situated such that they are at an angle relativeto an axis formed through the density bars 350 a, 350 b of the firstdensity band and are at the same angle relative to an axis formedthrough the density bars 354 a, 354 b of the third density band.

[0142] First, the needle guiding apparatus is placed on or near thepatient. Under the guidance of an MRI device or a CAT-scan device, themedical professional discerns the image plane 305 by aligning the seconddensity band with the target calyx. If two spots, corresponding to thetwo density bands 252 a, 252 b of the second density band, are seen inalignment with the target calyx 902, then the imaged section correspondswith the image plane 305. If one or no spots are seen in alignment withthe target calyx, then another section is viewed until an aligned stateis observed. Once the image plane 305 is defined, the guide shaft 284 isaligned within the image plane 305 (for example, by rotating theadjustment rod 264 in direction H or shifting the device along thepatient's skin). When the guide shaft 284 is aligned with the targetcalyx 902 and the MRI device source or CAT-scan source 910 along theimage plane 305, as shown in FIG. 51E, a particular image is formed. Theimage shown in FIG. 51F indicates that, when aligned, the section imagetaken by the MRI device or CAT-scan device down the image plane 305 willshow the first density band as two bar-shaped images 350 ai, 350 bi onthe top of the image, the second density band as two spot shaped-images352 ai, 352 bi in the middle, and the third density band as twobar-shaped images 354 ai, 354 bi on the bottom. The image 284 i of theguide shaft 284 is aligned with the target calyx 902. Also, if the guideshaft 284 is in the image plane 305 but not aligned with the targetcalyx 902, the dotted image of the guide shaft 284 indicates how a guideshaft 284 might be moved along direction Q to bring the guide shaft intoalignment with the target calyx 902. Once the guide shaft 284 isaligned, an entry needle can be inserted through the guide shaft 284.

[0143] Another embodiment of the invention, shown in FIGS. 15A-17, is aneedle guiding apparatus 134 that has several components: an entryneedle 136, a guide needle 138, a radiopaque donut 140, radiopaquecrosshairs 142, bar guides 144, an upper driving bar 146 (alternativelycalled the “upper bar”), a lower driving bar 148 (alternatively calledthe “lower bar”), and an adjustment rod 150. The entry needle 136 isaffixed in perpendicular fashion in the lower bar 148 and passes througha hole in the upper bar 146. The upper driving bar 146 is fixed to thebar guides 144 which are fixed to the cylindrical adjustment rod 150.The guide needle 138 is fixed in perpendicular fashion to the adjustmentrod 150. The radiopaque donut 140 is affixed to the adjustment rod 150or on or around the guide needle 138. The upper bar 146 is used to pushthe guide needle 138 into place. The lower bar 148 is used to drive theentry needle 136 through the guide needle 138 as it slides down the barguides 144. The coaxial arrangement of the radiopaque donut 140, guideneedle 138, and entry needle 136 is shown in FIG. 16 as a section takenthrough line A-A of FIG. 15A.

[0144] The apparatus 134 provides a means of aligning the entry needle136 with a target calyx. The entry site on the patient's back isidentified by aligning the radiopaque donut 140 on the distal end of theapparatus 134 with the radiopaque crosshairs 142 on the proximal end ofthe apparatus 134 and with the target calyx. This alignment can beviewed on the screen of a fluoroscope 152, and one example of the screendisplay of an aligned device 134 is shown in FIG. 17. An image 142 i ofthe cross-hairs 142 is shown encircled by a circular image 140 i of theradiopaque donut 140 and aligned with the target calyx 902.

[0145] The angle of the x-ray head and the fluoroscope mustapproximately match the angle of the apparatus 134 with respect to thepoint of entry on the patient and match the entry needle's 136 intendedentry trajectory. The device may be used in vertical orientation or mostother orientations that the medical professional may desire. Because theapparatus 134 has the ability for the needle 136 to enter in at an angleother than vertical, the medical professional can better customize theneedle's 136 approach into the kidney. An angle indicator can beincluded (not shown), for example, on the adjustment rod 150 to allow aphysician to discern the guide needle's 136 angle relative to thesurface of the patient's skin. The guide needle 138 is advanced about2-3 cm into the patient's back by the medical professional pushing onthe upper driving bar 146 which is fixed to the vertical guides 144 andcylindrical adjustment rod 150. Alternatively, the guide needle 138 maybe advanced by the medical professional grasping the adjustment rod 150at either end and pushing the adjustment rod 150 down on the patient'sback. The depth to which the guide needle 138 advances into the patientcan be adjustable. In this design, the adjustment rod 150 is ofsufficient length to allow the medical professional to use the device134 with his/her hands out of the x-ray field. The upper driving bar 146can be, for example, but without limitation, approximately 10 inches inlength, thereby allowing the medical professional to use the device 134without having his/her hands in the x-ray field. Once the guide needle138 has been positioned, the medical professional may re-check thealignment of the entry needle 136 using the distal radiopaque donut 140and the proximal radiopaque crosshairs 142. The entry needle 136 can beadvanced by the medical professional pushing down on the lower drivingbar 148, and the lower driving bar 148 moves over the vertical guides144. The lower driving bar 148 is slightly longer than the upper bar 146to allow the medical professional to push it down without also pushingthe upper bar 146. This design allows the lower bar 148 to be movedindependent of the upper bar 146. Alternative designs can involvelocking and unlocking the upper 146 and lower 148 bars to allowdependent or independent use and may be accomplished in a variety ofways. The lower bar 148, similar to the upper 146, is of sufficientlength to allow the medical professional to use the device withoutexposing his/her hands to the x-ray field. Prolonged exposure to x-raysare not desirable due to health risks. Therefore, any features whichallow the medical professional to keep his/her hands out of the x-rayfield are advantageous.

[0146] In addition to keeping a medical professional's hands away fromthe x-ray field, the present device 134, with greater stability thanconventional techniques, allows the medical professional to retaintactile feedback and also allows a syringe (not shown) to be attachedfor aspiration of urine. The device 134 also may be used whileperforming triangulation access if the medical professional so desires.Lastly, the device 134 or the entry needle 136 may have a feature whichallows the medical professional to detect when the target calyx has beenpierced, reducing the medical professional's reliance on tactilefeedback.

[0147] Another embodiment of the invention, shown in FIGS. 18A-21, is aneedle stage 154 and a separate entry needle 136. The needle stage 154includes a base 156, an alignment rod 150, a guide needle 138, aradiopaque donut 140 and a locking mechanism 160. The cylindricalalignment rod 150 is free to rotate about its axis in the base 156 ofthe needle stage 154 (as indicated with arrow L in FIG. 18A). The guideneedle 138, typically 12-14 gauge in diameter, is fixed in perpendicularfashion through the center of the alignment rod 150. The radiopaquedonut 140 is fixed on the alignment rod 150 or is fixed on or around theguide needle 138. The locking mechanism 160 (such as a screw) interactswith the base 156 and alignment bar 150 to prevent the components frommoving relative to one another.

[0148] The medical professional typically will hold the device bygrasping the ends of the alignment rod 150. The alignment rod 150 canbe, for example, but without limitation, approximately 10 inches inlength, thereby allowing the medical professional to use the device 154without exposure of his/her hands to the x-ray field. The physician canrotate the alignment rod 150 and thereby rotate the entry angle of theguide needle 138. The entry site on the patient's back will beidentified by aligning the image of the radiopaque donut 140 on oraround the image of the guide needle 138 with the target calyx 902. Theangle of the x-ray head and the fluoroscope must approximately match theentry angle of the guide needle 138 and the entry needle's 136 intendedentry trajectory. Once the radiopaque donut 140 is aligned with thetarget calyx 902, the medical professional may advance the guide needle138 into the patient's back by pushing down on the cylindrical alignmentrod 150. When the guide needle 138 is advanced 2-3 cm, the base 156 willbottom out on the surface of the patient's skin. The position of theguide needle 138 may then be locked into place by activating the lockingmechanism 160. This locking mechanism 160 can be, for example, butwithout limitation, a screw which drives through the base 156 and exertsperpendicular force onto the outer diameter of the cylindrical alignmentrod 150. The base 156 may also have a sticky underside which wouldprovide another means of securing it to the patient's skin or drape. Anangle indicator 162 can be included, for example, on the alignment rod150 to allow a medical professional to discern the guide needle's 138angle relative to the surface of the patient's skin (FIG. 19B). Thedepth to which the guide needle 138 advances into the patient can beadjustable.

[0149] Once the base 156 has been locked into position, the medicalprofessional may insert the entry needle 136, typically 18-22 gauge indiameter, into the guide needle 138. Variations of this entry needle 136are described throughout the specification. A conventional, commerciallyavailable entry needle may be advanced through the guide needle 138.Additionally, an entry needle with radiopaque crosshairs on its proximalend may be advanced through the guide needle 138, allowing the medicalprofessional to monitor the alignment of the needle during advancement.An entry needle 136 that may include radiopaque crosshairs 142 (shown asa section taken along line B-B through the entry needle 136 in FIG. 18B)may optionally be affixed in perpendicular fashion to a driving bar 158(FIG. 18A) that is similar to the one shown in FIGS. 15A-17, allowingthe medical professional to drive the entry needle 136 while keepinghis/her hands out of the fluoro field. A driving bar 158 may be providedwhich includes radiopaque crosshairs and allows attachment to acommercially available needle. The radiopaque crosshairs would alignwith the axis of the attached entry needle (in a manner similar to thatshown in FIG. 21), allowing any needle to have improved targetingcapabilities. A screen display of a fully aligned device 154 is shown inFIG. 21. A circular image 140 i of the radiopaque donut 140 encirclesthe image 136 i of the entry needle 136 and is aligned with an image 142i of the radiopaque cross-hairs and the target calyx 902. The initialalignment of the device (without the entry needle 136) would appear onthe screen display as the circular image 140 i of the radiopaque donut140 encircling the target calyx 902. This alignment would indicate thatthe guide needle 138 was in line with the target calyx 902 and that theentry needle 136 could be inserted through the guide needle 138 in aproper trajectory to reach the target calyx 902.

[0150] Another embodiment (not shown) of the invention adds the base 156and the locking mechanism 160 of the embodiment shown in FIGS. 18A-21onto the embodiment shown in FIGS. 15-17. The base 156 is disposed aboutthe adjustment rod 150 in a similar manner to the way the base 156 isshown disposed about the alignment rod 150 in FIGS. 18-21. The lockingmechanism 160 an operate in the same manner as described above.

[0151] Generally, the invention can save procedure time by giving themedical professional a tool to better control and align the movement ofan entry needle through a patient's back and into the target calyx of akidney. Additionally, the embodiment shown in FIGS. 15A-17 provides theadvantages of allowing activation of the device 134 without having amedical professional's hands in the x-ray field, allowing access to thetarget at an angle other than vertical, and allowing the medicalprofessionals to have tactile feedback during access. The embodimentshown in FIGS. 18A-21 provides an additional advantage by allowing themedical professional to lock the position of the guide needle 138.Finally, the embodiment combining the embodiment shown in FIGS. 15A-17with the embodiment shown in FIGS. 18A-21 provides at least theadvantages described above, in a single device.

[0152] Another embodiment of the invention, shown in FIGS. 28-30B,consists of a gun-like device 168 that has a housing 170 that containsthe inner workings of the device 168. A hole 182 on one end of thedevice 168 accepts an entry needle (shown in FIGS. 29 and 30A as needle184, 186, respectively), the device 168 provides a way to align theneedle 168 with, for example, a target calyx. Radiopaque crosshairs 176are disposed adjacent the hole 182. The entry site on the patient's backwill be identified as described above, using a guide needle 180 (forexample, a 14 gauge needle) which extends from the tip of the gun 168.The entry needle (for example, an 18 gauge entry needle) is locked intothe gun 168 on the same axis as the guide needle 180, such that, whenthe gun 168 is activated by moving the trigger 172 in direction M, theentry needle will pass through the guide needle 180. A disc 178 withspokes surrounds the guide needle 180 coaxially. The gun 168 has aradiopaque donut (not shown) on its distal end that is used with theradiopaque crosshairs 176 on its proximal end to align the entry needlein the gun 168 with the target calyx.

[0153] Once the gun 168 is rotated (with the x-ray head and thefluoroscope vertical), such that the target calyx and radiopaquecrosshair 176 are aligned in the radiopaque donut, the guide needle 180will be pushed vertically through the patient's skin and fatty tissue.The guide needle 180 will act as a guide for the entry needle to passthrough it. Once the tip of the guide needle 180 is pushed into place,approximately 2½-3 cm below the surface of the skin, the gun 168 isready for activation. When the gun 168 is fully aligned, the entryneedle will be driven into the target calyx through the guide needle bymanually squeezing the gun's trigger 172 in direction M. Guide needlesand entry needles of sizes other than 14 gauge and 18 gauge,respectively, are envisioned, and these needles may be coaxial, with oneneedle passing through the other needle, as described above.Additionally, many types of entry needles with various functionalitiesare possible. For example, the entry needle 184 shown in FIG. 29 cansample fluids at its distal end and the entry needle 186 shown in FIG.30A can detect light, particularly light produced by a light source 188shown in FIG. 30B. These entry needles and other types of entry needlesare described in more detail below. The gun 168 can also be used whileperforming triangulation access rather than a variation of the bullseyetechnique, if the medical professional so desires. Lastly, the device168 can optionally have a datum window 174. The datum window 174 can,for example, display at least one piece of datum, to allow the medicalprofessional to detect, for example, when the target calyx has beenpierced.

[0154] The device 192 shown in FIGS. 26-27 is simpler than the deviceshown in FIGS. 28-30B and also can be used to drive an entry needle 194in accordance with the invention. The entry needle 194 includes a smalldiameter needle. 206 (e.g. a 19 gauge needle) contained within a largerdiameter trocar 198 (e.g., an 18 gauge needle) having a hub 196. Theentry needle 194 is driven through a guide needle 202 at the distal endof the device 192. In operating the device, a medical professional wouldgrasp a distal handle 204 in one hand and move a proximal handle 208towards the distal handle 204, in direction N. This movement advancesthe entry needle 194 through the guide needle 202. The guide needle 202can be positioned in the patient in the manner as described for theembodiment shown in FIGS. 28-30B, such that the advanced entry needle194 is driven into the patient's tissue. This device 192 has radiopaquecrosshairs 208 disposed within the device (shown in cross section A-A inFIGS. 26 and 27) towards its proximal end and has a radiopaque donut 200disposed toward the distal end of the device 192. This sightingarrangement is similar to the embodiment described in FIGS. 28-30B.Except for the manner of advancing the entry needle 194, the device 192is targeted and used in a similar manner to that described for thedevice 168 described in FIGS. 28-30B.

[0155] Additionally, once a medical professional believes a target calyxhas been located with the entry needle through, for example, positioningunder the guidance of a fluoroscope or tactile feedback, the medicalprofessional will confirm access. One manner of confirming access withentry needles that are currently used is to remove an inner portion ofthe entry needle, attach a syringe, and to aspirate fluid from the tipof the entry needle. Blood in the syringe indicates that the target hasnot been reached while urine or contrast dye (previously injected intothe kidney to allow visualization of the kidney on the fluoroscopedisplay) in the syringe indicates that the target has been reached.

[0156] Several embodiments of an entry needle are shown in FIGS. 22-25.Now referring to FIGS. 22 and 23, an entry needle 184 includes a cannula224 in connection with (or as a single piece with) a “Y” shaped hub 228.The hub 228 has a branch 230 with a connector 222 at the proximal end ofthe branch 230. The cannula 224, which can be made of stainless steel,has an opening 210 at its distal end and contains a notched needle 214.The notched needle 214 rotates about an axis extending through thecenter of the cannula 224, and the notched needle can be about 18 toabout 21 gauge. The notched needle 214 is a hollow needle, with aportion of the wall of the needle 214 removed (i.e., a notch 212). In afirst position (FIG. 22), the portion of the notched needle 214 that isnot notched is aligned with the opening 210, preventing fluid locatedoutside of the entry needle 184 from entering into the cannula 224. In asecond position (FIG. 23), the notched portion 212 of the notched needle214 is aligned with the opening 210, allowing fluid located outside ofthe entry needle 184 to enter the cannula 224. A knob 216 with markingsfor “on” 218 and “off” 220 is attached to the notched needle 214 suchthat when the knob 216 is rotated, the notched needle 214 is rotated.Specifically, the “on” marking 218 is aligned with an indicator (notshown) when the notched needle is in the second position and the “off”marking 220 is aligned with the indicator when the notched needle is inthe first position. When in the second position, the notch 212 also isaligned with the branch 230 in the “Y” shaped hub 228 at the proximalend of the entry needle 214. Thus, fluid entering the cannula 224,travels along the inside of the cannula 224 and the notched needle 214until it reaches the branch 230 and is diverted into the branch 230. Aseal 226 at the proximal end of the cannula 224 prevents fluid fromescaping at the end of the cannula 224. The seal 226, for example, canbe an “O-ring” disposed about the notched needle 214. Once fluid hasentered the cannula 224 it flows and/or is drawn towards the proximalend of the entry needle 184. Fluid can be conducted along the cannula224 by attaching a syringe (not shown) to the connector 222, drawingback on the plunger in the syringe to create a vacuum, and drawing fluidthrough the device 184 towards the proximal end.

[0157] The entry needle 184 shown in FIGS. 22 and 23 avoids having toremove the inner portion of the entry needle in some current entryneedle designs by allowing for selectable fluid access at the turn of aknob. Removing this extra removal step can save time during theprocedure. Also, the syringe can be continuously attached to theconnector 222 to avoid having to continually attach and disengage thesyringe if kidney access must be confirmed multiple times. Additionally,the syringe can be used to introduce materials (such as additionalcontrast dye that is used to visualize the kidney on a fluoroscope) intoa patient through the cannula. Also, the notched needle 214 can beremoved once access is obtained and replaced with other medicalinstruments and/or a guide wire.

[0158] In another embodiment of a of an entry needle 186, shown in FIG.24, the entry needle 186 is capable of sensing entry into the targetcalyx of a kidney 900 by sensing, for example, light. A fiber opticlight source 188 can be inserted into the kidney 900, for examplethrough a ureter 904 into the kidney 900, and can emit light. The fiberoptic light source 188 can have other optional functions, for example,the source 188 can include a passage 240 for delivering contrast dye tothe kidney 900 to visualize the kidney under the fluoroscope and/or thesource 188 can have an inflatable balloon (not shown) for inflating andblocking dye from exiting the kidney 900 through the ureter 904. Theentry needle 186 has a cannula 232 connected with a hub 242. Inside thecannula, a fiber optic core 236 for sensing light within the kidney 900is provided. The core 236 transmits light through the cannula 232 to thehub 242. In the hub 242, a device 234, such as a light magnifier,magnifies the light received through the core 236 for display to amedical professional. Again, this embodiment can save time during theprocedure because target access can be confirmed without the additionalsteps required by current designs.

[0159] In another embodiment of an entry needle 190, shown in FIG. 25,the entry needle 190 is capable of sensing entry into the target calyxof a kidney with, for example, a chemical reaction. The entry needle 190has a cannula 244 connected to a hub 246 at the proximal end of theentry needle 190. An inner needle with a cap 248 (needle portion notshown) is located within the cannula 244 and is selectively removableto, for example, insert a guide wire. A reaction center 252 is locatedat the distal end of the cannula 224. This reaction center 252 canoperate in a variety of manners such that a signal is produced at anindicator 250. The indicator 250 can be located at one of or both of thehub 246 or the cap 248. A chemical reaction can occur at the tip of theneedle 190 to produce a signal at the hub 246 or cap 248. For example,urine and/or contrast dye in the kidney could react with a substance atthe tip of the needle 190 such that the reaction completes a circuit orallows a circuit to be completed so that an indicator 250 illuminateswith the completion of a circuit (or the device vibrates or the devicemakes an audible noise with the completion of a circuit). The reactioncenter 252 can be made to distinguish between the inside of a kidney(with such contents as urine and/or contrast dye) and the surroundingtissue (including blood). Alternatively, the reaction center 252 couldsense an optical property at the tip of the needle 190, and if theoptical property met a certain criterion or criteria, then a signalwould be generated in the proximal portion of the needle 190, such as atthe hub 246 or cap 248. For example, the needle 190 could detect lightabsorbance at certain wavelengths or reflection of high energyelectromagnetic radiation pulses (e.g., laser pulses), with the lightabsorbance at a particular wavelength or the reflection of energy beingindicative of the presence of a substance such as a contrast dye,indicating access to the target. In another embodiment, fluid can bedrawn into the cannula, and the chemical reaction can take placeanywhere along the length of the needle. Again, this embodiment can savetime during the procedure because target access can be confirmed withoutthe additional steps required by current designs.

[0160] In another embodiment of an entry needle 254, shown in detail inFIGS. 42A-42C, the entry needle 254 can indicate entry into a targetstructure such as a target calyx. Now referring to FIG. 42A, a housing322 contains a spring 314 surrounding a stylet 318. The stylet 318 isattached to a hub 312. A structure (not shown) may intervene between thestylet and the hub so that they are not in direct contact, but they areconnected. The stylet 318 has an extension 328 (for example, a piece ofmaterial that is connected with or a unitary part of the stylet 318 andthat may encircle all or a portion of the stylet 318) that contacts thespring 314, such that the spring 314 is enclosed within the housing 322and contacts the housing 322 at the proximal end of the housing 322 andcontacts the extension 328 at a more distal position in the housing 322.The stylet 318 is disposed within a cannula 316. In this embodiment thestylet 318 is coaxially disposed within the cannula 316. A connector 320is located at the proximal end of the cannula 316 such that it sealswith the cannula 316. The housing 322 has a distal portion that engagesthe connector 320. The spring 314 biases the stylet 318 and hub 312towards the distal end of the entry needle 254. The stylet 318 has ablunt edge 324 at its distal end, and the cannula 316 has a angled edge326 (that can be sharp) at its distal end. The angled edge 326 of thecannula 316 can facilitate movement through a patient's tissue. When theentry needle 254 is inserted into tissue, the stylet 318 is pushedtowards the proximal end of the entry needle 254 by the tissue (shown inFIG. 42B). Due to resistance from the tissue against the stylet 218, thespring 314 is compressed as the extension 328 is pushed proximally alongwith the rest of the stylet 318. Additionally, as the stylet 318 ispushed distally, the hub 312 raises from the housing 322 in a proximaldirection, indicating the presence of tissue at the distal end of theentry needle 254. Additionally, as shown in FIG. 42C, the housing 320,stylet 318, and hub 312, as an assembly, can be removed from the cannula216 and connector 320. Removal can occur, for example, when the cannula216 is desired to be connected to a syringe (not shown) to sample fluidsat the distal tip of the cannula 326 and/or when a guide wire is to beinserted through the cannula 316.

[0161] One example of operation of the entry needle 254 is shown inFIGS. 44A-44D and FIG. 45. In FIG. 42A, the entry needle 254 is insertedthrough a patient's skin 908 and into the kidney 900. The resistancefrom the patient's tissue causes the stylet 318 to move proximally,compresses the spring 314, and raises the hub 312. FIG. 45 shows anenlarged view of the position shown in FIG. 44A with the entry needle254 held by a medical professional 1001. As the entry needle 254 entersthe target calyx 902 (characterized by an absence of dense tissue suchas that surrounding the target calyx 902) in the kidney 900, the spring314 decompresses in the absence of resistance from the patient's tissue.The stylet 318 moves distally and the hub 312 lowers, indicating entryinto the target calyx 902. The entry needle 254 would work in mostinstances where the target is a cavity or void. The blunt edge of thestylet 318 in this embodiment is an added measure of safety because whenthe stylet 318 extends distally, if there is any inadvertent contactwith tissue within the calyx, the contact will be relatively benign dueto the blunt edge. Once entry occurs, the stylet 318, hub 312, andhousing 322, as an assembly, are removed from the connector 322 andcannula 316 (FIG. 44C), leaving the connector 322 and cannula 316 behindas an assembly (FIG. 44D). The cannula 316 is still located in thetarget calyx 902, and, optionally, a syringe (not shown) can be attachedto the connector 322 to sample fluid at the tip of the cannula 316 toconfirm entry into the target calyx 902. Alternatively, a guide wire canbe placed through the cannula 316 into the target calyx 902. The entryneedle 254 also can be used in conjunction with a needle guidingapparatus, for example, as shown in FIG. 31. The entry needle 254 wouldindicate access to the target calyx 902 in the manner described above,but would be targeted using a needle guiding apparatus. This combinationcan further reduce the procedure time because not only is accuracy andease of entry needle placement increased with needle guiding apparatusaccording to the invention, but also confirmation of access into thetarget calyx is simplified, for example, by viewing the raising andlowering of the hub of the entry needle according to the invention.

[0162] In an alternative embodiment of the entry needle 254 shown inFIGS. 42A-42C, an entry needle 330 with a different distal endconfiguration is shown in FIGS. 43A-43C. The entry needle 330 has thesame components as the entry needle 254 shown in FIGS. 42A-42C exceptthat the distal end of the stylet 318 has an angled edge 332 and thedistal end of the cannula 316 has a blunt edge 334. The angled edge 332of the stylet 318 can be sharp to facilitate movement of the stylet 318through a patient's tissue. Referring to FIG. 43A, the entry needle 330is in a starting position similar to that shown in FIG. 42A. As shown inFIG. 43B, as the stylet 318 is pushed through tissue, the stylet 318 ispushed towards the proximal end of the device 330, the spring 314 iscompressed, and the hub 312 raises, indicating that the tip of thedevice 330 is in a more dense tissue. However, the entry needle 330 isdesigned such that the stylet 318 does not retract fully into thecannula 318 (as it does in the embodiment shown in FIG. 42B). Thus, theangled edge 332 of the stylet 318 is exposed to tissue as the device 330is inserted into a patient. When the entry needle 330 enters a cavity,such as a target calyx, the spring 314 decompresses, the stylet 318moves towards the distal end of the entry needle 330, and the hub 312lowers, indicating entry into the cavity. The hub 312, housing 322, andstylet 318 can be removed as an assembly from the cannula 316 andconnector 320, as shown in FIG. 43C. The cannula 316 and connector 320are left behind as an assembly, positioned within the patient. A syringe(not shown) optionally can be attached to the connector 320 to withdrawfluids and confirm access to the target, and/or a guide wire can beinserted down the cannula 316. The entry needle 330 can be useful insituations besides gaining access to the kidney or other cavitiesincluding procedures to gain access to cardiovascular system vessels.The indicator hub 312 would indicate access into a vessel without bloodbeing ejected from the patient, and a guide wire could be inserted.

[0163] Any of the entry needles according to the invention, in additionto other entry needles not specifically described herein, are useablewith needle guiding apparatus according to the invention.

[0164] Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention asclaimed. Accordingly, the invention is to be defined not by thepreceding illustrative description but instead by the spirit and scopeof the following claims.

What is claimed is:
 1. A needle guiding apparatus comprising: a basedefining an opening extending therethrough; a guide assembly includingat least one passage and being disposed within the opening, the guideassembly being rotatable about at least one axis; and an imaging sightdisposed adjacent the at least one passage.
 2. The apparatus of claim 1wherein the guide assembly comprises a first transmission elementbetween a first location within the opening and a second location remotetherefrom, the first transmission element for transferring angularmovement between the second location and the first location, themovement at the first location occurring about a first one of the atleast one axis.
 3. The apparatus of claim 2 wherein the firsttransmission element comprises a first pulley proximate the firstlocation and disposed coaxially with the first axis of rotation.
 4. Theapparatus of claim 3 wherein the first transmission element furthercomprises a guide shaft defining at least a portion of the at least onepassage.
 5. The apparatus of claim 2 wherein the first transmissionelement comprises a belt for transferring angular movement between thefirst location an the second location.
 6. The apparatus of claim 2wherein the first transmission element comprises a control shaftconnected to a second pulley proximate the second location.
 7. Theapparatus of claim 6 further comprising a lock for preventing movementof the first transmission element.
 8. The apparatus of claim 2 whereinthe guide assembly further comprises a second transmission element fortransferring angular movement about a second one of the at least oneaxis.
 9. The apparatus of claim 8 wherein the second transmissionelement comprises an adjustment rod rotatable about the second axisextending through the adjustment rod.
 10. The apparatus of claim 9wherein the imaging sight comprises a radiopaque core of the adjustmentrod.
 11. The apparatus of claim 9 further comprising a lock forpreventing movement of the adjustment rod.
 12. The apparatus of claim 9wherein the imaging sight comprises at least two parallel bands disposedwithin the adjustment rod.
 13. The apparatus of claim 8 wherein thefirst axis and the second axis are substantially perpendicular.
 14. Theapparatus of claim 1 wherein the imaging sight comprises a radiopaqueband disposed within the base.
 15. The apparatus of claim 1 wherein theguide assembly comprises an adjustment rod.
 16. The apparatus of claim15 wherein the adjustment rod is rotatable about an axis extendingthrough the adjustment rod.
 17. The apparatus of claim 15 wherein theadjustment rod is rotatable about an axis extending through the at leastone passage.
 18. The apparatus of claim 1 wherein the guide assemblycomprises a turret disposed within the opening.
 19. The apparatus ofclaim 18 wherein the turret includes an adjustment rod.
 20. Theapparatus of claim 19 wherein the turret is rotatable about an axisextending through the opening.
 21. The apparatus of claim 19 wherein theadjustment rod is rotatable about an axis extending through theadjustment rod.
 22. The apparatus of claim 1 wherein the guide assemblycomprises a guide needle.
 23. The apparatus of claim 1 wherein the guideassembly comprises a ball and socket joint disposed within the base. 24.The apparatus of claim 23 wherein the guide assembly further comprises aguide shaft defining a portion of the at least one passage.
 25. Theapparatus of claim 23 further comprising a control arm connected to theguide assembly.
 26. The apparatus of claim 25 further comprising asecond ball and socket joint connected to the control arm, thereby toreplicate the movement of the second ball and socket joint at the guideassembly.
 27. The apparatus of claim 26 wherein the second joint iscapable of locking into a position.
 28. The apparatus of claim 1 whereinthe imaging sight is disposed coaxially about the at least one passage.29. The apparatus of claim 1 wherein the imaging sight comprises a ring.30. The apparatus of claim 1 wherein the imaging sight comprises atleast one cross-hair.
 31. The apparatus of claim 1 wherein the imagingsight includes a material that is detectable with a fluoroscope.
 32. Theapparatus of claim 31 wherein the material that is detectable with afluoroscope comprises a radiopaque material.
 33. The apparatus of claim1 wherein the guide assembly includes at least two of the passagesdisposed at known angles relative to the base.
 34. The apparatus ofclaim 1 further comprising at least one clamp for attaching theapparatus to a fixed surface.
 35. The apparatus of claim 1 wherein theguide assembly is capable of locking into a position.
 36. The apparatusof claim 1 wherein the guide assembly is rotatable about at least twoaxes and wherein at least two of the axes are substantiallyperpendicular.
 37. The apparatus of claim 1 further comprising an entryneedle, the needle capable of inserting through the at least onepassage.
 38. The apparatus of claim 37 wherein the entry needlecomprises: a first assembly comprising, a housing; a stylet extendinginto the housing and biased towards a distal end of the entry needle;and a hub adjacent the housing at a proximal end of the entry needle,the hub in connection with the stylet; and a second assembly comprisinga cannula surrounding the stylet, wherein the first assembly and thesecond assembly seal together and are separable.
 39. The apparatus ofclaim 38 wherein the hub is movable from a first position to a secondposition, the hub in the first position indicating that the entry needleis impeded by a tissue and the hub in the second position indicatingthat the entry needle is substantially unimpeded by the tissue.
 40. Theapparatus of claim 38 wherein the stylet includes a blunt edge at adistal end of the stylet.
 41. The apparatus of claim 38 wherein thecannula includes an angled edge at a distal end of the cannula.
 42. Theapparatus of claim 38 wherein the stylet includes an angled edge at adistal end of the stylet.
 43. The apparatus of claim 38 wherein thecannula includes a blunt edge at a distal end of the cannula.
 44. Theapparatus of claim 38 further comprising a connector connected with thecannula for attaching a medical device to the entry needle.
 45. Theapparatus of claim 37 wherein the entry needle comprises an inner needlecoaxially surrounded by a cannula having an outer wall defining a lumen.46. The apparatus of claim 45 wherein the cannula has an opening in theouter wall proximate a distal end of the entry needle and a branchproximate a proximal end of the entry needle and wherein the innerneedle includes a notch.
 47. The apparatus of claim 46 wherein the innerneedle is rotatable from a first position to a second position, thenotched inner needle in the first position allowing communicationbetween the opening and the branch and the notched inner needle in thesecond position preventing communication between the opening and thebranch.
 48. The apparatus of claim 46 wherein the branch is capable ofattaching to a suction device.
 49. The apparatus of claim 37 wherein theentry needle includes an electromagnetic energy sensor.
 50. Theapparatus of claim 37 wherein the entry needle includes a chemicalsensor.
 51. The apparatus of claim 1 wherein the guide assembly does notprotrude past at least one side of the base.
 52. A method for aiming aneedle guiding apparatus comprising the steps of: providing a needleguiding apparatus comprising a base having an opening, a guide assemblydefining at least one passage and disposed within the opening, the guidebeing rotatable about at least one axis, and an imaging sight disposedadjacent the at least one passage; aligning the imaging sight with atleast a portion of a target and with an energy source; and viewing thesight on a display.
 53. The method of claim 52 wherein the imaging sightis selected from the group consisting of a ring of radiopaque material,a bar of radiopaque material, a cross-hair of radiopaque material, adiamond shape of radiopaque material, cross-hairs of radiopaquematerial, perpendicular bars of radiopaque material, and combinationsthereof.
 54. The method of claim 53 wherein the viewing step comprisesviewing the imaging sight on the display, the imaging sight appearing tosurround the at least a portion of a target and at least a portion ofthe guide assembly, thereby indicating proper alignment.
 55. The methodof claim 54 wherein the guide assembly comprises a guide shaft.
 56. Themethod of claim 55 wherein the viewing step comprises viewing theimaging sight on the display, the imaging sight appearing to surroundthe guide shaft and the at least a portion of a target, therebyindicating proper alignment.
 57. A needle guiding apparatus comprising:a base defining an opening extending therethrough; a guide assemblycomprising a turret rotatably mounted in the opening and an adjustmentrod rotatably mounted in the turret, the guide assembly including atleast one passage therethrough; and an imaging sight disposed adjacentat least one passage.
 58. The apparatus of claim 57 wherein the turretincludes a groove for interlocking with pins from the base, thereby toallow rotation of the turret within the base.
 59. The apparatus of claim57 wherein the turret is associated with the base using a friction fit,thereby to allow rotation of the turret within the base.
 60. Theapparatus of claim 57 wherein the guide assembly does not protrudebeyond at least one side of the base.
 61. A needle guiding apparatuscomprising: a base including a socket; a guide assembly including atleast one passage therethrough and including a ball articulable withinthe socket and a guide shaft proximate the ball; and an imaging sightdisposed adjacent at least one passage.
 62. The apparatus of claim 61further comprising a connecting rod in operable connection with theguide assembly and with a mechanism, the mechanism being remote from theguide assembly, thereby to replicate movements of the mechanism at theguide assembly.
 63. The apparatus of claim 62 wherein the mechanismcomprises a base assembly including a socket, a ball being articulablein the socket, and a shaft proximate the ball.
 64. The apparatus ofclaim 62 further comprising a lock, thereby to prevent movement of theguide assembly.
 65. The apparatus of claim 61 wherein the base includesan opening extending therethrough and the guide assembly is disposedwithin the opening.
 66. A needle guiding apparatus comprising a base, adome, and a guide assembly including a stop and defining a passage, suchthat the guide assembly is positionable at various locations through thedome and the guide assembly does not protrude beyond at least onesurface of the base.
 67. The apparatus of claim 66 wherein the domeincludes an imaging sight.
 68. A needle guiding apparatus comprising: abase defining an opening extending therethrough; a guide assemblycomprising a turret rotatable within the opening, the turret defining atleast two passages therethrough, the passages being at known angles ofentry relative to the base; and an imaging sight adjacent at least onepassage.
 69. A needle guiding apparatus comprising: a base defining anopening extending therethrough; a guide assembly comprising a guideneedle including a passage therethrough, the guide needle beingrotatable about an axis that extends through the base and issubstantially perpendicular to the guide needle; and an imaging sightadjacent the passage.
 70. The apparatus of claim 69 further comprisingat least one driving bar for inserting an entry needle through thepassage.
 71. The apparatus of claim 70 further comprising at least onebar guide for sliding at least one driving bar along a predeterminedrange of motion.
 72. The apparatus of claim 69 further comprising atleast one driving bar for applying force to the guide assembly.
 73. Theapparatus of claim 72 further comprising at least one bar guide, whereinat least one driving bar is affixed to the at least one bar guide suchthat applied force is conveyed from the at least one driving bar to theguide assembly.
 74. A needle guiding apparatus comprising: a basedefining an opening extending therethrough; a guide assembly comprisingan adjustment rod rotatable about an axis extending through theadjustment rod and a guide needle extending through the adjustment rodand defining a passage extending therethrough; and an imaging sightadjacent the passage.
 75. The apparatus of claim 74 further comprising alock for preventing movement of the alignment rod.
 76. The apparatus ofclaim 74 further comprising at least one driving bar associated with anentry needle for applying force to the entry needle, the entry needlepassing through the passage.
 77. The apparatus of claim 76 furthercomprising at least one bar guide for sliding at least one driving baralong a predetermined range of motion.
 78. The apparatus of claim 74comprising at least one driving bar for applying force to the guideassembly.
 79. The apparatus of claim 78 further comprising at least onebar guide, wherein at least one driving bar is affixed to the at leastone bar guide such that applied force is conveyed from the at least onedriving bar to the guide assembly.
 80. An entry needle comprising: afirst assembly comprising, a housing; a stylet extending into thehousing and biased towards a distal end of the entry needle; and a hubadjacent the housing at a proximal end of the entry needle, the hub inconnection with the stylet; and a second assembly comprising a cannulasurrounding the stylet, wherein the first assembly and the secondassembly seal together and are separable.
 81. The apparatus of claim 80wherein the hub is movable from a first position to a second position,the hub in the first position indicating that the entry needle isimpeded by a tissue and the hub in the second position indicating thatthe entry needle is substantially unimpeded by the tissue.
 82. Theapparatus of claim 80 wherein the stylet includes a blunt edge at adistal end of the stylet.
 83. The apparatus of claim 80 wherein thecannula includes an angled edge at a distal end of the cannula.
 84. Theapparatus of claim 80 wherein the stylet includes an angled edge at adistal end of the stylet.
 85. The apparatus of claim 80 wherein thecannula includes a blunt edge at a distal end of the cannula.
 86. Theapparatus of claim 80 further comprising a connector connected with thecannula for attaching a medical device to the entry needle.